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

Trial Status: Active

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.

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE

California

Orange
Children's Hospital of Orange County
Status: ACTIVE
San Francisco
University of California San Francisco
Status: ACTIVE
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Trial Phase Phase O

Trial Type Treatment

Lead Organization
New York Medical College

  • Primary ID NYMC 575
  • Secondary IDs NCI-2021-00444
  • Clinicaltrials.gov ID NCT03719105