Summary

Eligibility
for people ages 1-31 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Michelle Hermiston (ucsf)
Headshot of Michelle Hermiston
Michelle Hermiston

Description

Summary

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.

Official Title

Pilot Study Using Induction Chemo-immunotherapy Followed by Consolidation With Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Keywords

NK-Cell Lymphoma, NK-Cell Leukemia, Peripheral T Cell Lymphoma, Lymphoma, Leukemia, T-Cell Lymphoma, Lymphoma, T-Cell, Peripheral, Dexamethasone, Prednisone, Cyclophosphamide, Ifosfamide, Doxorubicin, Methotrexate, Etoposide, Brentuximab Vedotin, pralatraxate,, calaspargase pegol

Eligibility

You can join if…

Open to people ages 1-31

  • Patients must weigh at least 10 kilograms at the time of the study enrollment.
  • Diagnosis

    Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms: COHORT 1

  • Aggressive NK cell leukemia (ICD-O code 9948/3)
  • Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2
  • Enteropathy-associated T-cell lymphoma (ICD-O code 9717/3)
  • Hepatosplenic T-cell lymphoma (ICD-O code 9716/3)
  • Peripheral T-cell lymphoma, non-otherwise specified (ICD-O code 9702/3)
  • Angioimmunoblastic T-cell lymphoma (ICD-O code 9705/3)
  • Other mature T- and NK-cell neoplasm histologies will considered after case-by-case discussion with Study Chairs and executive Vice-Chair Patients with lymphoma must have stage III or IV disease (See Appendix III for Staging).
    • Organ Function Requirements

      Adequate liver function defined as:

  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
  • ALT (SGPT) < 3 x ULN for age.

    Adequate cardiac function defined as:

  • Shortening fraction of ≥ 27% by echocardiogram, or
  • Ejection fraction of ≥ 50% by radionuclide angiogram.

    Adequate pulmonary function defined as: • Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry > 92% while breathing room air unless current dysfunction is due to the lymphoma, in which case the patient is eligible.

You CAN'T join if...

  • Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)
  • Patients with active CNS disease.
  • Patients with stage I or stage II disease (See Appendix III for Staging).
  • Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of NHL.
  • Previous steroid treatment and/or radiation treatment are not allowed unless they are used for emergency management. Patients who have received emergency irradiation and/or steroid therapy will be eligible only if started on protocol therapy not more than one week from the start of radiotherapy or steroids.
  • Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarchal.
  • Lactating females, unless they have agreed not to breastfeed their infants.
  • Patients with Down syndrome.
  • Patients taking CYP3A4 substrates with narrow therapeutic indices. Patients (COHORT 2 ONLY) chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices (See Appendix V). The topical use of these medications (if applicable) is allowed.
  • Patients taking CYP3A4 inhibitors. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment (See Appendix V). The topical use of these medications (if applicable) is allowed.
  • Patients taking CYP3A4 inducers. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment (See Appendix V).

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Children's Hospital Orange County accepting new patients
    Orange California 92968 United States

Lead Scientist at University of California Health

  • Michelle Hermiston (ucsf)
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 142 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
New York Medical College
ID
NCT03719105
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated