OncoMatch/Clinical Trials/NCT03719105
Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
Is NCT03719105 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Non-Hodgkin Lymphoma
Disease stage
Required: Stage III, IV
Excluded: Stage I, II
Demographics
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 →Frequently asked questions
Is NCT03719105 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 31 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages