Study on Azacitidine and Venetoclax as Ongoing Treatment for Patients with Acute Myeloid Leukemia in Remission

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04062266

Provider View

This clinical trial is exploring how well the combination of azacitidine and venetoclax works as a maintenance treatment for patients whose acute myeloid leukemia (AML) is in remission. These drugs aim to prevent cancer from returning by stopping cancer cells from growing and spreading.

Patient Parameters

Program Overview

This phase II study is testing the effectiveness of azacitidine and venetoclax in keeping acute myeloid leukemia (AML) in remission. These medications work by targeting cancer cells to stop them from growing and spreading. The trial aims to see if this combination can help patients stay cancer-free longer and improve their overall survival.

Description

The main goal of this study is to see how long patients with acute myeloid leukemia (AML) can stay in remission when treated with azacitidine and venetoclax. Researchers will also look at overall survival, event-free survival, and how long the remission lasts. They will monitor the safety and side effects of the treatment and study how it affects any remaining cancer cells.

Patients will receive azacitidine either as an injection under the skin or through an IV for five days, and venetoclax as a pill for 14 days. This treatment cycle repeats every 28 days for up to 24 cycles, as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have follow-up visits at 30 days and then every 6-12 months.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with acute myeloid leukemia (AML) in their first remission who are not immediate candidates for a stem cell transplant.
  • Patients who have received intensive chemotherapy to achieve remission must have completed initial treatment and at least one follow-up treatment cycle. They should join the study within two months of their last treatment.
  • Patients who have received lower intensity therapy must have completed at least two treatment cycles after achieving remission.
  • Patients with measurable residual disease can join at any time.
  • Must have a performance status score of 3 or lower, indicating they are able to care for themselves with some limitations.
  • Must have adequate organ function, including:
    • Total bilirubin level at or below 1.5 times the normal limit.
    • Creatinine level at or below 2.5 times the normal limit.
  • Must have adequate bone marrow function, including:
    • Neutrophil count above 0.5 x k/uL.
    • Platelet count at or above 30 x k/uL.
  • Women of childbearing age must have a negative pregnancy test and agree to use effective birth control during and for 30 days after treatment.
  • Men with female partners of childbearing age must agree to use effective birth control during and for 30 days after treatment.
  • Must be able to understand and sign informed consent.

Exclusion Criteria

  • Diagnosis of acute promyelocytic leukemia (APL) or AML with specific genetic markers.
  • Uncontrolled health issues, such as infections, heart problems, or psychiatric conditions that would interfere with the study.
  • Active central nervous system (CNS) disease.
  • Allergies to any study medications.
  • Pregnant or breastfeeding women, or those planning to become pregnant during the study.
  • History of AML outside the bone marrow, except controlled CNS involvement.
  • Participation in another clinical trial for treatment.

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