Clinical Trial

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

Recruiting Early Phase 1

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.

Protocol Amendment History 7 amendments

This ClinicalTrials.gov record has been amended 7 times since 2018-10-23; most recent amendment 2025-08-07.

Status change: Not Yet Recruiting → Recruiting 2019-03-11

Trial Details

NCT Number	NCT03719105
Lead Sponsor	New York Medical College Collaborators: University of Alabama at Birmingham
Conditions	NK-Cell Lymphoma, NK-Cell Leukemia, Peripheral T Cell Lymphoma
Enrollment	40 participants
Start Date	2019-03-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-08