A Phase II Study of Azacitidine Alone and with Venetoclax in Untreated Patients with Acute Myeloid Leukemia Who Cannot Receive Standard Induction Therapy

Full Title

M15-656: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination with Azacitidine Versus Azacitidine in Treatment Naïve Subjects with Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

Purpose

The initial chemotherapy that patients with acute leukemia receive is called induction therapy. Not all patients can receive intensive induction therapy, however. Patients with acute myeloid leukemia (AML) who cannot tolerate intensive induction chemotherapy typically receive just the drug azacitidine, which is given intravenously (by vein). In this study, researchers want to see if adding venetoclax to azacitidine is safe and more effective than azacitidine alone in these patients.

Venetoclax blocks a protein called Bcl-2, a protein that helps cancer cells survive and resist the effects of anticancer treatments. By blocking Bcl-2, venetoclax could kill leukemia cells and/or make them more vulnerable to the effects of other cancer treatments, such as azacitidine. Venetoclax is approved for treating chronic lymphocytic leukemia; its use in this study is considered investigational. It is taken orally (by mouth).

Patients in this study will be randomly assigned to receive azacitidine plus either venetoclax or a placebo (inactive drug).

Eligibility

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

  • Patients must have newly diagnosed AML and be ineligible for intensive induction therapy due to age (over 75) or physical condition.
  • Patients age 75 and older must be able to walk and do routine activities for more than half of their normal waking hours.
  • In addition to patients with good physical function, this study is also open to those ages 18-84 who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.

For more information and to inquire about eligibility for this study, please contact Dr. Jacob Glass at 212-639-8353.

Protocol

18-011

Phase

III

Investigator

Co-Investigators