A Phase IIB Study of BST-236 in Patients with Newly Diagnosed Acute Myeloid Leukemia

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Full Title

A Phase 2b, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults with Newly-Diagnosed Acute Myeloid Leukemia, Not Eligible for Standard Induction Therapy

Purpose

Induction therapy with chemotherapy, such as high-dose cytarabine, is a standard first treatment for newly diagnosed acute myeloid leukemia (AML), but not all patients can tolerate the intensity of the treatment because of older age or their overall health. In this study, researchers are evaluating the safety and effectiveness of the investigational drug BST-236 in patients who cannot undergo standard induction therapy.

BST-236 is an inactive form of cytarabine that is activated when it enters a patients’ cells, and may therefore have fewer side effects than standard cytarabine. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed, previously untreated AML and be ineligible for standard induction therapy due to older age (75 or older) or other health problems.
  • Patients who have received hypomethylating drugs for myelodysplastic syndromes (such as azacitidine or decitabine) and whose disease transformed to AML may participate.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 212-639-3842.

Protocol

18-497

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators