drugset / Trial / NCT04752163
DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This phase I/II trial studies the effect of DS-1594b with or without azacitidine, venetoclax, or mini-HCVD in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has come back (recurrent) or not responded to treatment (refractory). Chemotherapy drugs, such as azacitidine, venetoclax, and mini-HCVD, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. DS-1594b may inhibit specific protein bindings that cause blood cancer. Giving DS-1594b, azacitidine, and venetoclax, or mini-HCVD may work better in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia.
Timeline
- Start
- 2021-03-25
- Primary completion
- 2023-11-08
- Completion
- 2023-11-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | — | Intravenous |
| Subject | DS-1594b | Unknown | 20 mg | Oral |
| Subject | DS-1594b | Unknown | 50 mg | Oral |
| Subject | DS-1594b | Unknown | 70 mg | Oral |
| Subject | DS-1594b | Unknown | 100 mg | Oral |
| Subject | Venetoclax | Small molecule | — | Oral |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intrathecal |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Vincristine | Small molecule | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |