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

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 ce

Trial Details

NCT ID

NCT03719105

Phase

EARLY_PHASE1

Sponsor

New York Medical College

Status

RECRUITING

Cancer Type

Non-Hodgkin Lymphoma Lymphoma

Interventions

Methotrexate
pralatraxate,
Ifosfamide
Dexamethasone
Etoposide
calaspargase pegol

Locations (sample)

Birmingham, Alabama, United States|33.52066,-86.80249
Orange, California, United States|33.78779,-117.85311
San Francisco, California, United States|37.77493,-122.41942
Grand Rapids, Michigan, United States|42.96336,-85.66809
Valhalla, New York, United States|41.07482,-73.77513

Key Eligibility Criteria

Patients must weigh at least 10 kilograms at the time of the study enrollment.
Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms:
Aggressive NK cell leukemia (ICD-O code 9948/3)
Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2

For full eligibility, visit ClinicalTrials.gov.

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