drugset / Trial / NCT03719105
Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
Phase 0
Recruiting
40 enrolled
New York Medical College
University of Alabama at Birmingham · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-03-01
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brentuximab Vedotin | Monoclonal antibody | — | — |
| Subject | Calaspargase Pegol | Protein / enzyme biologic | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Dexamethasone | Small molecule | — | — |
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | Etoposide | Small molecule | — | — |
| Subject | Ifosfamide | Small molecule | — | — |
| Subject | Methotrexate | Small molecule | — | — |
| Subject | Prednisone | Other / unclassified | — | — |
| Subject | pralatraxate, | Unknown | — | — |