OncoMatch/Clinical Trials/NCT03719105
Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
Is NCT03719105 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments for nk-cell lymphoma.
Treatment: Methotrexate · pralatraxate, · Ifosfamide · Dexamethasone · Etoposide · calaspargase pegol · cyclophosphamide · Doxorubicin · Prednisone · Brentuximab Vedotin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Disease stage
Required: Stage III, IV
Excluded: Stage I, II
Prior therapy
Cannot have received: cytotoxic chemotherapy
Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of NHL.
Cannot have received: steroid
Exception: emergency management only; protocol therapy must start within one week from start of radiotherapy or steroids
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.
Cannot have received: radiation therapy
Exception: emergency management only; protocol therapy must start within one week from start of radiotherapy or steroids
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.
Lab requirements
Liver function
total bilirubin ≤ 1.5 x uln for age; alt (sgpt) < 3 x uln for age
Cardiac function
shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama · Birmingham, Alabama
- Children's Hospital Orange County · Orange, California
- University of California San Francisco · San Francisco, California
- Helen De Vos · Grand Rapids, Michigan
- New York Medical College · Valhalla, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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