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

NCT04752163

Phase 1/2 Terminated 17 enrolled M.D. Anderson Cancer Center
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

EvaluationDrugModalityDoseRoute
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