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

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

Outcome

Outcome not reported

Stopped (Business): “supporting/funding source decided to de-prioritize and stop development of DS-1594”

Publications

Numata M, Haginoya N, Shiroishi M, Hirata T, Sato-Otsubo A, Yoshikawa K, Takata Y, Nagase R, Kashimoto Y, Suzuki M, Schulte N, Polier G, Kurimoto A, Tomoe Y, Toyota A, Yoneyama T, Imai E, Watanabe K, Hamada T, Kanada R, Watanabe J, Kagoshima Y, Tokumaru E, Murata K, Baba T, Shinozaki T, Ohtsuka M, Goto K, Karibe T, Deguchi T, Gocho Y, Yoshida M, Tomizawa D, Kato M, Tsutsumi S, Kitagawa M, Abe Y. A novel Menin-MLL1 inhibitor, DS-1594a, prevents the progression of acute leukemia with rearranged MLL1 or mutated NPM1. Cancer Cell Int. 2023 Feb 25;23(1):36. doi: 10.1186/s12935-023-02877-y.

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