drugset / Trial / NCT02723994
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.
Timeline
- Start
- 2016-09-30
- Primary completion
- 2026-03-03
- Completion
- 2026-03-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ruxolitinib | Small molecule | — | — |
| Background | Asparaginase Erwinia chrysanthemi | Protein / enzyme biologic | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Cytarabine | Small molecule | — | — |
| Background | Dexamethasone | Small molecule | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | — |
| Background | Pegaspargase | Protein / enzyme biologic | — | — |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Thioguanine | Small molecule | — | — |
| Background | Vincristine | Small molecule | — | — |