A Phase II Study of BST-236 in People with Acute Myeloid Leukemia or Myelodysplastic Syndrome

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Full Title

A Phase 2, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults Unfit for Intensive Chemotherapy with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes

Purpose

The purpose of this study is to assess the safety and effectiveness of the drug BST-236 in people with recurrent or persistent acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) who are not able to have standard induction therapy due to older age or health problems. BST-236 is an inactive form of the standard leukemia drug cytarabine, and it becomes activated when it enters the cells it targets. Because BST-236 does not release cytarabine until it is in a patient’s cells, it may prevent the side effects someone with health problems or older age would normally have after receiving standard induction chemotherapy.

BST-236 is given intravenously (by vein) each day for the first six days of each course of treatment. Patients will need to stay in the hospital for the six days of the first (induction) course.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have recurrent or persistent AML or high-risk MDS and not be eligible for standard induction chemotherapy because of health problems or older age.
  • Patients may not have had prior treatment with drugs other than hypomethylating agents (HMA) or combinations of venetoclax with HMA or low-dose cytarabine.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Eytan Stein at 646-608-3749.

Protocol

22-179

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators