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

Description

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.

Conditions

NK-Cell Lymphoma, NK-Cell Leukemia, Peripheral T Cell Lymphoma

Study Overview

Study Details

Study overview

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.

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

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

Condition
NK-Cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Alabama, United States, 35223

Orange

Children's Hospital Orange County, Orange, California, United States, 92968

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Grand Rapids

Helen De Vos, Grand Rapids, Michigan, United States, 49503

Valhalla

New York Medical College, Valhalla, New York, United States, 10595

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients must weigh at least 10 kilograms at the time of the study enrollment.
  • * Diagnosis
  • * 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
  • * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
  • * ALT (SGPT) \< 3 x ULN for age.
  • * Shortening fraction of ≥ 27% by echocardiogram, or
  • * Ejection fraction of ≥ 50% by radionuclide angiogram.
  • * 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).

Ages Eligible for Study

1 Year to 31 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

New York Medical College,

Mitchell Cairo, MD, STUDY_DIRECTOR, New York Medical College

Study Record Dates

2026-12-31