A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL
a study on Diffuse Large B-Cell Lymphoma Lymphoma Non-Hodgkin Lymphoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedestimated completion
Description
Summary
This is an open-label, multicentre study to characterize the safety and efficacy of the human anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.
Official Title
A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)
Keywords
Diffuse Large B-cell Lymphoma DLBCL CD19 monoclonal antibody MOR00208 MOR208 lenalidomide Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse
Eligibility
For people ages 18 years and up
Major Inclusion Criteria:
- Age >18 years
- Histologically confirmed diagnosis of DLBCL
- Tumour tissue for central pathology review and correlative studies must be provided.
- Patients must have:
- relapsed and/or refractory disease
- at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
- received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy
- Eastern Cooperative Oncology Group 0 to 2
- Patients not considered in the opinion of the investigator eligible, or patients unwilling to undergo intensive salvage therapy including ASCT
- Patients must meet the following laboratory criteria at screening:
- absolute neutrophil count ≥1.5 × 109/L
- platelet count ≥90 × 109/L
- total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
- alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or <5 × ULN in cases of liver involvement
- serum creatinine clearance ≥60 mL/minute
- Females of childbearing potential (FCBP) must:
- not be pregnant
- refrain from breastfeeding and donating blood or oocytes
- agree to ongoing pregnancy testing
- commit to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
- Males (if sexually active with a FCBP) must
- use an effective barrier method of contraception
- refrain from donating blood or sperm
- In the opinion of the investigator the patients must:
- be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
- be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.
Major Exclusion Criteria:
- Patients who have:
- other histological type of lymphoma
- primary refractory DLBCL
- a history of "double/triple hit" genetics
- Patients who have, within 14 days prior to Day 1 dosing:
- not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
- undergone major surgery or suffered from significant traumatic injury
- received live vaccines.
- required parenteral antimicrobial therapy for active, intercurrent infections
- Patients who:
- were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN)
- have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
- have undergone previous allogenic stem cell transplantation
- have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
- concurrently use other anticancer or experimental treatments
- Prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ≥5 years prior to screening.
- Patients with:
- positive hepatitis B and/or C serology.
- known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
- CNS lymphoma involvement
- history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent.
Locations
- MorphoSys Research Site
Redondo Beach California 90277 United States - MorphoSys Research Site
Bakersfield California 93309 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- MorphoSys AG
- ID
- NCT02399085
- Phase
- Phase 2
- Study Type
- Interventional
- Last Updated