A Study of Tamibarotene with Venetoclax and Azacitidine in People with Previously Untreated Acute Myeloid Leukemia with Certain Genetic Changes

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Full Title

Tamibarotene in Combination with Venetoclax and Azacitidine in Previously Untreated Adult Patients Selected for RARA-positive AML Who Are Ineligible for Standard Induction Therapy

Purpose

The purpose of this study is to assess the safety of adding the investigational drug tamibarotene to treatment with venetoclax and azacitidine in people newly diagnosed with acute myeloid leukemia. The participants in this study will have AML with a RARA genetic alteration, which can trigger cancer cell growth. Tamibarotene targets the RARA protein on cancer cells, and this targeting action may stop or slow the growth of cancer cells.

Tamibarotene and venetoclax are taken orally (by mouth) and azacitidine is given intravenously (by vein) or by subcutaneous injection (under the skin).

Eligibility

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

  • Participants must have AML that has not yet been treated and cannot be treated with standard intensive chemotherapy due to the patient’s age (75 or older) or other health factors.
  • Patients’ cancers must contain the RARA genetic mutation.

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

Protocol

21-414

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators