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Transplants clinical trials at University of California Health

86 in progress, 41 open to eligible people

Showing trials for
  • Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant

    open to eligible people ages up to 30 years

    Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.

    at UCSF

  • Tabelecleucel in Participants With Epstein-barr Virus-associated Diseases

    open to all eligible people

    The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with Epstein-Barr virus (EBV) associated diseases.

    at UC Davis UCLA

  • TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant

    open to eligible people ages 18 years and up

    This study is a comparison of the analgesic efficacy of transversus abdominis plane (TAP) blocks with ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.

    at UC Davis

  • See if an iPhone Weight Management App Can Help Promote Weight Loss in Adolescents and Young Adults After a Stem Cell Transplant

    open to eligible people ages 13-30

    This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion of weight loss in adolescents and young adults after a stem cell transplant. This study may help researchers learn more about how adolescents and young adults can lose weight and develop healthy eating habits.

    at UCLA

  • Allogeneic Engineered Hematopoietic Stem Cell Transplant (HCT) Lacking the CD33 Protein, and Post-HCT Treatment With Mylotarg, for Patients With CD33+ AML

    open to eligible people ages 18-70

    This is a Phase 1/2a, multicenter, open-label, first-in-human (FIH) study of VOR33 in participants with AML who are undergoing human leukocyte antigen (HLA)-matched allogeneic hematopoietic cell transplant (HCT).

    at UCSD

  • Allograft Dysfunction in Heart Transplant

    open to eligible people ages 18 years and up

    The investigators will evaluate for early evidence of cardiac allograft dysfunction by cardiac MRI and single cell sequencing to determine underlying molecular and macroscopic causes.

    at UCSD

  • Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Hematopoietic Stem Cell Transplant Patients

    open to eligible people ages 13-30

    Pilot study enrolling obese post HSCT (hematopoietic stem cell transplantation) patients at the hematology/oncology clinic at the Mattel Children's Hospital, University of California, Los Angeles. Parameters include percent over the 95th percentile (%BMIp95), zBMI, fasting metabolic metrics, addictive eating habits, and motivation for change.

    at UCLA

  • BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)

    open to eligible people ages 18 years and up

    Primary Objectives: - Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR - Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: - To assess the overall efficacy of BIVV020 in prevention or treatment of AMR - To characterize the safety and tolerability of BIVV020 in kidney transplant participants - To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants - To evaluate the immunogenicity of BIVV020

    at UCLA UCSF

  • CGM in Kidney Transplant Recipients

    “Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”

    open to eligible people ages 18 years and up

    The investigators want to study the impact CGM (continuous glucose monitoring) has on patients glycemic control as determined by time in range (TIR 70-180 mg/dL) in the Diabetic Kidney Transplant population.

    at UC Davis

  • Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma

    open to eligible people ages 1-31

    Patients are in 2 cohorts: Cohort 1: dexamethasone, methotrexate, ifosfamide, pegaspargase, and etoposide (modified SMILE) chemotherapy regimen alone and pembrolizumab in children, adolescents, and young adults with advanced stage NK lymphoma and leukemia Cohort 2: combining pralatrexate (PRX) (Cycles 1, 2, 4, 6) and brentuximab vedotin (BV) (Cycles 3, 5) to cyclophosphamide, doxorubicin, and prednisone in children, adolescent, and young adults with advanced peripheral T-cell lymphoma (non-anaplastic large cell lymphoma or non-NK lymphoma/leukemia) . Both groups proceed to allogeneic stem cell transplant with disease response.

    at UCSF

  • COVID Protection After Transplant-Immunosuppression Reduction

    open to eligible people ages 18 years and up

    This study will enroll individuals who have: - Completed primary series of mRNA COVID-19 vaccine, and - An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.

    at UCSD UCSF

  • Daratumumab and Belatacept for Desensitization

    open to eligible people ages 18-65

    Some kidney transplant candidates have a very low chance of getting a kidney transplant because their immune systems are "highly sensitized" to most kidney donors. Being "highly sensitized" means that they will likely have to wait a long time (more than 5 years) before an acceptable donor is found for them or, they never receive a compatible donor, and die on waitlist. The purpose of this study is to find out whether two drugs, daratumumab (Darzalex®), and belatacept (Nulojix®), can make these kidney transplant candidates less sensitized, and make it easier and quicker to find a kidney donor for them.

    at UCSF

  • EDIT-301 for Autologous Hematopoietic Stem Cell Transplant (HSCT) in Participants With Transfusion-Dependent Beta Thalassemia (TDT)

    open to eligible people ages 18-35

    The purpose of this study is to evaluate the safety, tolerability, and efficacy of treatment with EDIT-301 in adult participants with Transfusion Dependent beta Thalassemia

    at UCSF

  • MT-401 in Patients With AML Following Stem Cell Transplant

    open to eligible people ages 18 years and up

    This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing).

    at UCLA UCSD

  • Identifying Best Approach in Improving Quality of Life and Survival After a Donor Stem Cell Transplant in Older, Medically Infirm, or Frail Patients With Blood Diseases

    open to eligible people ages 20 years and up

    This phase II/III trial studies the best approach in improving quality of life and survival after a donor stem cell transplant in older, weak, or frail patients with blood diseases. Patients who have undergone a transplant often experience increases in disease and death. One approach, supportive and palliative care (SPC), focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects. While a second approach, clinical management of comorbidities (CMC) focuses on managing multiple diseases, other than cancer, such as heart or lung diseases through physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education. Giving SPC, CMC, or a combination of both may work better in improving quality of life and survival after a donor stem cell transplant compared to standard of care in patients with blood diseases.

    at UCSF

  • Immunological Tolerance in Patients With Mismatched Kidney Transplants

    open to eligible people ages 18 years and up

    This study seeks to determine if administration of the drug belumosudil (KD025) will be safe and improve transplant tolerance in subjects undergoing combined Human Leukocyte Antigen (HLA) single haplotype-matched related or 0-3 antigen (at A, B, C, DR) HLA mismatched unrelated living donor kidney and hematopoietic stem cell transplantation.

    at UCLA

  • LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.

    open to eligible people ages 18 years and up

    The goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation. The main questions it aims to answer are: - Is LAM-001 safe in these patients? - Is LAM-001 effective in slowing BOS progression? Participants will: - Be randomly assigned to inhale either LAM-001 or placebo (a look-alike substance that contains no active drug) daily for 48 weeks - Attend 10 study visits (mixture of in-person and telehealth) over the 48 week period - Undergo pulmonary function testing, bronchoscopy, lab testing, and physical examination - Submit weekly home spirometry monitoring Researchers will compare participants assigned to LAM-001 versus placebo to see if LAM-001 is safely tolerated and to assess the effectiveness of LAM-001 on slowing BOS progression.

    at UCSF

  • MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation

    open to eligible people ages 18 years and up

    Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.

    at UCSF

  • Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients

    open to eligible people ages 18 years and up

    This investigator-initiated post-marketing study will evaluate the role of Hispanic ethnicity on drug dosing of Envarsus in first-time stable renal transplant recipients. Tacrolimus trough drug levels will be studied as a primary endpoint at 24 hours after drug dosing and at steady state (e.g., trough level at 3 months post conversion) and secondary compliance assessments will be done by pill counts at clinic visits. Secondary outcomes will be the safety of once a day dosing as well as assessment of graft rejection and graft failure. In addition, concentration/dose ratios will be analyzed. The results of this study will provide important information about dosing of once a day tacrolimus (Envarsus) in Hispanic kidney transplant patients, which represents the largest growing group of patients with End-Stage Renal Disease

    at UCSD

  • Retro-active Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-identical Kidney Transplants

    open to eligible people ages 18 years and up

    The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).

    at UCLA

  • Tegoprubart in Patients Undergoing Kidney Transplantation

    open to eligible people ages 18-100

    This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.

    at UC Davis UC Irvine UCLA UCSF

  • AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in Kidney Transplant Recipients (KTRs). The study includes two parts. The phase II part will evaluate the safety of AntiBKV in KTRs and establish proof of concept. The phase III part will assess the efficacy of AntiBKV in KTRs. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every 4 weeks). Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Based on an interim analysis after phase II total sample size for the trial will be defined. Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a 4-week interval. Seven days following the first IMP administration, participants will be re-evaluated for BKV DNAemia and, if appropriate, changes of immunosuppressive treatment will be started. After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and as clinically indicated.

    at UC Davis UCLA

  • Structured Program of Exercise for Recipients of Kidney Transplantation

    open to eligible people ages 50 years and up

    Older patients with end- stage kidney disease (ESKD) are at very high risk for functional impairment. Kidney transplantation (KT) has the potential to ameliorate the detrimental effects of ESKD on physical activity and functional status. However, KT alone may not meet the full extent of this potential, particularly for older or more impaired adults. In fact, activity declines immediately post-KT and fails to return to expected levels even 5 years post-KT. Older patients waitlisted for KT (most of whom are on dialysis) are therefore reliant on their pre-KT levels of exercise, which are also predictive of post-KT mortality. "Prehabilitation" has been used in other surgical populations to minimize functional loss, and a structured exercise program may be beneficial in the pre- KT setting. However, few waitlisted patients are able to participate in typical exercise interventions due to barriers such as severe fatigue. Older patients have additional barriers such as further mobility impairment and requiring substantial caregiver support. Therefore for older living donor kidney transplant candidates, it is necessary to address issues such as specifics of coaching, timing, and importantly, incorporate caregiver participation. The overall objective of this proposal is to adapt a previously developed 8- week, home- based, structured exercise program among older (≥50 years) dialysis patients awaiting living donor KT, with a focus on caregiver involvement. The investigators will trial the exercise program as compared to usual care. The investigators will then pilot the refined intervention in a total of 72 patient-caregiver dyads, 48 of whom will undergo the proposed intervention (24 with caregiver participation, 24 without). The primary outcomes for the pilot will be change in physical performance and activity from baseline to after the intervention, along with measurements of exploratory quality of life outcomes. In addition, the investigators will measure these same outcomes at 3- months post KT to evaluate for a durable effect of the intervention. An additional post-transplantation outcome of interest will be number of days hospitalized within 3 months of transplantation.

    at UCSF

  • Desensitization of Chronic Kidney Disease in Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen

    open to eligible people ages 18-70

    The primary objective of the study is to assess the safety and tolerability of REGN5459 (Part A) or REGN5458 (Part B) as monotherapy in patients with chronic kidney disease (CKD) who need kidney transplantation and are highly sensitized to human leukocyte antigen (HLA). The secondary objectives of the study are to determine/assess the following for REGN5459 (Part A) or REGN5458 (Part B): - Dose regimen(s) that result in a clinically meaningful reduction of anti-HLA alloantibody levels - Effect on calculated panel-reactive antibody (cPRA) levels - Time to maximal and clinically meaningful reduction in anti-HLA alloantibody levels - Duration of the effect of study drug on the reduction of anti-HLA alloantibodies - Effect on circulating immunoglobulin (Ig) classes (isotypes) - Pharmacokinetics (PK) properties - Immunogenicity

    at UC Irvine UCSF

  • Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor

    open to eligible people ages 18 years and up

    The purpose of this study is to find out if an investigational treatment will allow kidney transplant recipients to better accept their new kidney and stop immunosuppressive medicines. This study is for kidney transplant recipients who receive a kidney from a sibling donor. The investigational treatment is started after kidney transplant. It begins with a regimen of a drug called rabbit anti-thymocyte globulin (rATG) combined with radiation therapy (known as total lymphoid irradiation, or TLI) to the lymph nodes and spleen. This is followed by an infusion of blood stem cells, which will be donated by the same sibling who donated their kidney. Researchers think that this treatment allows immune cells from the donor and recipient to live side by side, a condition referred to as "mixed chimerism." Mixed chimerism may help create a state of "tolerance" in kidney transplant recipients in which all immunosuppressive medications can be stopped without rejection of the transplanted kidney. This study will test whether (1) the investigational treatment will allow patients to stop immunosuppressive medications after their kidney transplant and (2) if the treatment impacts the rate of kidney rejection and the side effects of immunosuppressive medications.

    at UCLA

  • ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant

    open to eligible people ages 18-75

    The goal of this clinical trial is to compare ARINA-1 plus Standard of Care vs Standard of Care alone. The main question it aims to answer are: - Evaluate the effectiveness of ARINA-1 in preventing bronchiolitis obliterans syndrome (BOS) progression in participants with a bilateral lung transplant - To evaluate the effectiveness of ARINA-1 on improving quality of life decline and preventing or delaying the use of augmented immunosuppression in participants with pre-BOS relative to SOC. Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants will have clinic visits at weeks 32, 40, and 48. Participants will also have a telehealth visit on day 2 and phone calls to assess adverse events (AEs), serious adverse events (SAEs), and review patient education will occur during weeks 5, 8, 36, and 44.

    at UCLA UCSD

  • Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy

    open to all eligible people

    The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

    at UC Davis UCLA UCSD

  • TEE and Dysphagia in Lung Transplantation

    open to eligible people ages 18 years and up

    The primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation. Transesophageal echocardiography (TEE) (creates pictures of the heart from inside the participants body) is routinely performed for all lung transplantations at the University of California, Los Angeles (UCLA) and it is the standard of care. Patients are randomized to two groups. The intervention group would limit the number of TEE clips (# pictures taken) per case. The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist. The investigators hypothesize that reduction in TEE imaging during lung transplantation will reduce dysphagia.

    at UCLA

  • Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)

    open to eligible people ages 1-49

    This phase II trial tests whether treosulfan, fludarabine, and rabbit antithymocyte globulin (rATG) work when given before a blood or bone marrow transplant (conditioning regimen) to cause fewer complications for patients with bone marrow failure diseases. Chemotherapy drugs, such as treosulfan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fludarabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. rATG is used to decrease the body's immune response and may improve bone marrow function and increase blood cell counts. Adding treosulfan to a conditioning regimen with fludarabine and rATG may result in patients having less severe complications after a blood or bone marrow transplant.

    at UCSD UCSF

  • Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

    open to eligible people ages 1 month to 99 years

    To perform an receiver operating characteristic (ROC) analysis, define a threshold and quantify the sensitivity and specificity of US SWE for risk stratification of patients into three categories as defined by the European Bone Marrow Transplant (EBMT) adult and pediatric criteria: no sinusoidal obstruction syndrome (SOS), mild to moderate SOS, and severe to very severe SOS. Secondarily, the investigators would also like to quantify the temporal relationship between US SWE changes and SOS diagnosis according to various clinical criteria (Modified Seattle, Baltimore, EBMT consortium).

    at UCSF

  • XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.

    at UCSD

  • AlloSure Lung Assessment and Metagenomics Outcomes Study

    open to eligible people ages 18 years and up

    ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap for surveillance post-transplant. This study aims to investigate the clinical utility of AlloSure®-Lung for surveillance of the spectrum of rejection and infection events in concert with standard of practice (SOP) post-transplant medical care in a robust lung transplant population. The AlloID™ metagenomics NGS plasma test will be collected and performed for research to validate this molecular diagnostic tool versus SOP microbiologic techniques for detection of allograft infection events.

    at UCSF

  • Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive A Kidney Transplant

    open to eligible people ages 18-70

    The primary objective of the study is to assess adverse events (AEs) and serious adverse events (SAEs) in kidney transplant recipients previously treated with REGN5459 or REGN5458 in the R5459-RT-1944 study. The secondary objectives of the study are to evaluate each of the following in kidney transplant recipients previously treated with REGN5459 or REGN5458: - Rates and classification of antibody-mediated and T-cell-mediated kidney allograft rejection - Graft survival - Allograft function - Delayed allograft function - Anti-human leukocyte antigen (HLA) alloantibody levels and calculated panel-reactive antibody (cPRA) - Emergence of de novo donor-specific antibodies - Circulating immunoglobulin (Ig) classes (isotypes) - Pharmacokinetics (PK) of REGN5459 or REGN5458

    at UC Irvine UCSF

  • Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers

    open to eligible people ages 18 years and up

    This study collects blood and tissue samples for research of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)-related cancers. Collecting blood and tissue samples and studying biomarkers in the laboratory may help doctors to learn how are biologic or genetic factors related to HIV and cancers that occur commonly in people living with HIV.

    at UCSF

  • Delirium in Children Undergoing Stem Cell Transplantation

    open to eligible people ages up to 21 years

    Children undergoing stem cell transplants are at risk for delirium, a temporary change in thinking and behavior. This study will define delirium rates, risk factors, and outcomes. Our eventual goal is to reduce delirium in this population.

    at UCSF

  • Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events

    open to eligible people ages 18 years and up

    Prospective determination of the clinical utility of measurable residual disease (MRD) testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (alloHCT).

    at UCSF

  • OCS Heart Perfusion Post-Approval Registry

    open to eligible people ages 18 years and up

    The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.

    at UCSF

  • Sponsor-Initiated OCS Heart Perfusion Registry

    open to all eligible people

    OHP-II Registry is a sponsor-initiated, multi-center, observational post-approval registry.

    at UCSF

  • PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)

    open to eligible people ages 18 years and up

    The ProActive registry is a longitudinal, multi-center study with a prospective arm observing clinical care for patients receiving physician ordered Prospera, an allograft rejection test, and a historical control arm collecting data on cases at the same sites whose kidney allograft rejection status was managed with Serum Creatinine SCr/estimated Glomerular Filtration Rate eGFR. This registry will compare patient management and outcomes in patients who receive Prospera (Prospera arm) to the outcomes of the historical control group (control arm) to determine Prospera's clinical utility. High-risk subjects defined as having a biopsy-demonstrated rejection event or at least one pre-existing Donor Specific Antibody DSA with total Mean Fluorescent Intensity MFI>3000 or a calculated Panel Reactive Antibodies cPRA>70% will be followed for an additional period up to 24 months in both the Prospera arm and historical control arm.

    at UC Davis UC Irvine UCLA

  • TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

    open to eligible people ages up to 24 years

    Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited. This is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic (alloHSCT) or autologous hematopoietic stem cell transplantation (autoHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.

    at UCSF

  • TruGraf® Long-term Clinical Outcomes Study

    open to eligible people ages 18 years and up

    This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.

    at UC Davis UCLA

  • Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation sequencing (NGS) at screening, following high-dose therapy (HDT) and autologous stem cell transplant (ASCT).

    at UCLA UCSD UCSF

  • Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

    Sorry, not currently recruiting here

    The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

    at UCSF

  • Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies

    Sorry, currently not accepting new patients, but might later

    The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.

    at UCSD

  • BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Sickle Cell Disease

    Sorry, in progress, not accepting new patients

    This is an open label, multicenter, Phase 1/2 study in approximately eight adults with severe Sickle Cell Disease (SCD). The study will evaluate the safety, tolerability, and efficacy of autologous hematopoietic stem cell transplantation using BIVV003.

    at UC Davis UCSF

  • Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

    Sorry, not currently recruiting here

    The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.

    at UCLA

  • Advancing Transplantation Outcomes in Children

    Sorry, not yet accepting patients

    This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

    at UCLA UCSD

  • S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration

    Sorry, not currently recruiting here

    Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.

    at UC Davis UC Irvine

  • Biomarker-Guided CNI Substitution In Kidney Transplantation

    Sorry, not currently recruiting here

    800 adult first time kidney transplant recipients will be enrolled in the Observational Study and followed to evaluate their Human Leukocyte Antigen (HLA)-DR/DQ molecular mismatch (mMM) score as a risk-stratifying prognostic biomarker. Six months after transplant the study will identify those who meet the eligibility criteria for the Nested Randomized Control Trial (RCT). 300 eligible subjects will be randomized 2:1 to abatacept or Standard of care (SOC) in the randomization and followed for 18 months monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM). The primary objective of the Observational Study is to test the validity of the HLA-DR/DQ mMM score as a prognostic biomarker for stratification of post-transplant alloimmune risk. Whereas the objective of the Nested RCT is to test whether a superior outcome in kidney function (primary endpoint), as well as secondary endpoints (neurocognitive function, and life participation PROM), will be achieved in patients who are transitioned from Tacrolimus (TAC) to abatacept, while maintaining efficacy (freedom from biopsy proven acute rejection).

    at UCLA

  • Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

    Sorry, in progress, not accepting new patients

    This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after chemotherapy in treating patients with newly diagnosed neuroblastoma that is likely to come back or spread. Giving chemotherapy to the entire body before a stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

    at UC Davis UCSF

  • Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.

    at UCSF

  • Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients

    Sorry, in progress, not accepting new patients

    This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.

    at UC Davis UCLA UCSF

  • Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

    Sorry, in progress, not accepting new patients

    This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional intense chemotherapy followed by peripheral blood stem cell rescue. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.

    at UC Davis UCSF

  • Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma

    Sorry, in progress, not accepting new patients

    This phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma. Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy and/or autologous stem cell transplant may kill any remaining tumor cells.

    at UCSF

  • Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System

    Sorry, in progress, not accepting new patients

    This phase III trial studies the side effects of combination chemotherapy, 3-dimensional conformal radiation therapy, and an autologous peripheral blood stem cell transplant, and to see how well they work in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.

    at UCSF

  • COVID Protection After Transplant - Sanofi GSK (CPAT-SG) Study

    Sorry, not currently recruiting here

    An open label, non-randomized pilot study in kidney transplant recipients who received a completed primary series and bivalent booster of mRNA based COVID-19 vaccine and have =<2500 U/mL SARS-CoV-2 S antibody concentration using the Roche Elecsys(R) anti-RBD assay. Up to 80 participants will be enrolled in this study. Eligible participants will receive a dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine candidate.. The primary objective is to determine whether a booster dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine will elicit an increased SARS-CoV-2 antibody response in participants who have failed to maintain an antibody titer >2500 U/mL (using the Roche Elecsys(R) anti-RBD assay) to 2 or more doses of mRNA based COVID-19 vaccine

    at UCSD UCSF

  • Dietary Intervention to Improve Kidney Transplant Outcomes

    Sorry, in progress, not accepting new patients

    Randomized controlled trial of a curriculum intervention teaching patients to eat a whole-food plant-based dietary pattern versus standard of care in kidney transplant recipients within the first few months of transplant

    at UC Davis

  • Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)

    Sorry, in progress, not accepting new patients

    The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in single lung transplant recipients.

    at UCLA UCSF

  • Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2)

    Sorry, in progress, not accepting new patients

    The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in double lung transplant recipients.

    at UCLA UCSF

  • Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)

    Sorry, accepting new patients by invitation only

    The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

    at UCLA UCSF

  • Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant

    “Study looking at stem cell gene therapy to treat patients with HIV and lymphoma”

    Sorry, in progress, not accepting new patients

    This phase I/II trial studies the side effects and best dose of gene therapy in treating patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to therapy or came back after an original response receiving stem cell transplant. In gene therapy, small stretches of deoxyribonucleic acid (DNA) called "anti-HIV genes" are introduced into the stem cells in the laboratory to make the gene therapy product used in this study. The type of anti-HIV genes and therapy in this study may make the patient's immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with HIV-1.

    at UC Davis UCSD UCSF

  • High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant

    Sorry, in progress, not accepting new patients

    This phase II randomized trial studies how well high dose flu vaccine works in treating children who have undergone done stem cell transplant. Higher dose flu vaccine may build a better immune response and may provide better protection against the flu than the standard vaccine.

    at UCSF

  • HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.

    at UCLA UCSD UCSF

  • Improving Medication Adherence in Adolescents Who Had a Liver Transplant

    Sorry, in progress, not accepting new patients

    The study's aim is to test a tailored telemetric intervention to reduce rejection incidence by improving medication adherence in a group of adolescent liver transplant recipients identified as nonadherent by a marker (the Medication Level Variability Index, MLVI).

    at UCLA UCSF

  • Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

    Sorry, in progress, not accepting new patients

    This pilot clinical trial studies induction therapy followed by iobenguane I 131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide phosphate, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy. Giving radioisotope therapy, chemotherapy, and peripheral stem cell transplant may kill more tumor cells.

    at UCSF

  • Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies how well Lactobacillus plantarum works in preventing acute graft versus host disease in children undergoing donor stem cell transplant. Lactobacillus plantarum may help prevent the development of gastrointestinal graft versus host disease in children, adolescents, and young adults undergoing donor stem cell transplant.

    at UCSF

  • Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.

    at UC Davis UCSD UCSF

  • Lung Transplant READY CF 2: A Multi-site RCT

    Sorry, not currently recruiting here

    Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Rates of death without transplant are higher for people with CF who are members of marginalized communities, including those with Black race, Hispanic ethnicity, or low socioeconomic status. Increasing awareness of lung transplant among people with CF, and promoting understanding of the risks and benefits of transplant, can potentially reduce the number of people with CF who die without a lung transplant. The CF Foundation (CFF) lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant. These guidelines recommend annual conversations with people with CF once their forced expiratory volume in one second (FEV1) is <50% predicted. Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions and/or making decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant. Investigators also aim to understand whether there are unique factors that affect people with CF from communities with decreased access to transplant ("communities of concern"). Study involvement will span 6 months and study activities will involve the following: - Four Zoom research sessions (15-30 minutes each) - Survey assessments - Access to a research website that contains educational resources about lung transplant - Audio recording of a routine CF clinic visit to determine if and how lung transplant is discussed between a participant and his/her/their CF doctor

    at UCLA

  • Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients

    Sorry, in progress, not accepting new patients

    This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.

    at UCSF

  • Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65

    Sorry, in progress, not accepting new patients

    In this research study, we are looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. In this study, HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival by at least 9 months or more, recognizing that particular subgroups may benefit more compared to others.

    at UCSD UCSF

  • Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

    at UCSD UCSF

  • Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score

    Sorry, in progress, not accepting new patients

    The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).

    at UCLA

  • Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

    “Targeted chemotherapy/placebo for relapsed (returned after a period of improvement) or refractory (does not respond to treatment) lymphoma”

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.

    at UC Davis UC Irvine UCSD UCSF

  • Tocilizumab in Cardiac Transplantation

    Sorry, not currently recruiting here

    The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.

    at UCLA UCSD

  • Tocilizumab in Lung Transplantation

    Sorry, not currently recruiting here

    This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids). The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance immunosuppression plus placebo (saline) as defined by a composite endpoint of a) CLAD, b) listed for re-transplantation, and c) death

    at UCLA

  • Zevalin Before Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

    “Is radioimmunotherapy before a donor peripheral blood stem cell transplant an effective treatment for non-Hodgkin's Lymphoma?”

    Sorry, in progress, not accepting new patients

    This phase II trial studies how well ibritumomab tiuxetan before donor peripheral blood stem cell transplant works in treating patients with relapsed or refractory non-Hodgkin lymphoma. Giving rituximab, antithymocyte globulin, and total-lymphoid irradiation (TLI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving rituximab, antithymocyte globulin, and TLI before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody before a donor peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin lymphoma.

    at UC Davis

  • Clinical Trials in Organ Transplantation Extension Study

    Sorry, in progress, not accepting new patients

    The purpose of the study is to continue to follow subjects who were enrolled in the CTOT-20 CLAD Phenotypes study. Subjects will provide clinical data and complete quality of life questionnaires that will be used to determine the clinical factors associated with the development of Chronic Lung Allograft Dysfunction (CLAD) after lung transplant.

    at UCLA

  • Development of Non-invasive Cell-free DNA to Supplant Invasive Biopsy in Heart Transplantation

    Sorry, in progress, not accepting new patients

    This is a prospective, multicenter observational, unblinded, longitudinal cohort study. Subjects will be enrolled into the study prior to or at the time of heart transplantation. All subjects will follow the center's standard of care surveillance schedule. Blood samples will be collected for Prospera testing at the time any surveillance or for-cause testing, which may include endomyocardial biopsy (EMB), echocardiography or other cardiac imaging studies, and/or molecular testing, is performed.

    at UCSD

  • Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

    Sorry, in progress, not accepting new patients

    This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.

    at UC Davis UCLA UCSF

  • ExoFlo in Abdominal Solid Organ Transplant Patients

    Sorry, not accepting new patients

    This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression to severe or life-threatening condition related to rejection of an abdominal solid organ transplant, at risk of worsening allograft function, or at risk of complications from current immunosuppressive therapeutic regimens.

    at UCSF

  • Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.

    Sorry, accepting new patients by invitation only

    Primary Objectives: Long-term safety of BIVV003 in participants with severe sickle cell disease (SCD) and ST- 400 in participants with transfusion-dependent beta-thalassemia (TDT) Secondary Objectives: - Long-term efficacy of the biological treatment effect of BIVV003 in SCD - Long-term efficacy of the clinical treatment effect of BIVV003 on SCD-related clinical events - Long-term efficacy of the biological treatment effect of ST-400 in TDT - Long-term efficacy of the clinical treatment effect of ST-400 in TDT

    at UCSF

  • Long Term Follow up of the LTOG Cohort

    Sorry, accepting new patients by invitation only

    The purpose of the study is to follow participants who enrolled in the Lung Transplant Outcomes Group. Clinical data, functional assessments, and surveys will be collected to determine long term graft function and functional status of lung transplant recipients.

    at UCSF

  • Surveillance HeartCare® Outcomes Registry

    Sorry, in progress, not accepting new patients

    This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.

    at UCLA UCSD UCSF

  • DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)

    Sorry, in progress, not accepting new patients

    Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics

    at UCSF

  • Trifecta-Heart cfDNA-MMDx Study

    Sorry, not currently recruiting here

    Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.

    at UCLA

  • VIRTUUS Children's Study

    Sorry, in progress, not accepting new patients

    The objective of the VIRTUUS Children's Study is to adapt identified and validated adult noninvasive diagnostic and prognostic biomarkers for the characterization of allograft status in pediatric recipients of kidney allografts.

    at UCLA UCSD

Our lead scientists for Transplants research studies include .

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