Study on Azacitidine and Venetoclax for Initial Treatment and Maintenance in Elderly Patients with Acute Myeloid Leukemia (AML)

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03466294

Provider View

This clinical trial is exploring the effectiveness of using azacitidine and venetoclax as a first treatment for elderly patients with acute myeloid leukemia (AML) who have not been treated before. The study will also look at using venetoclax alone for ongoing maintenance in patients who respond well to the initial treatment.

Patient Parameters

Program Overview

The study aims to find out if a combination of azacitidine and venetoclax can effectively treat elderly patients with acute myeloid leukemia (AML) who have not received any prior treatment. Initially, both drugs will be given together to see if they can reduce the disease to a minimal level. If successful, the treatment will continue with venetoclax alone to maintain the response.

Description

This is a Phase 2 clinical trial for elderly patients who have not previously been treated for acute myeloid leukemia (AML). Up to 42 participants will be enrolled in the study. All participants will receive a combination of azacitidine and venetoclax until their disease is reduced to a minimal level. Once this is achieved, azacitidine will be stopped, and the dose of venetoclax will be lowered to a maintenance level to help keep the disease under control.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of non-APL AML and be unable or unwilling to undergo standard intensive chemotherapy due to other health issues.
  • Must not have received any prior treatment for AML, except for hydroxyurea, which is allowed.
  • Must be 60 years of age or older.
  • Must have a life expectancy of at least 12 weeks.
  • Must have a performance status score of 2 or lower, indicating they are able to carry out all self-care but unable to carry out any work activities.
  • Must have adequate kidney function, with a creatinine clearance of at least 30 mL/min.
  • Must have adequate liver function, with specific limits on liver enzyme levels and bilirubin.
  • Non-sterile male participants must use contraception and avoid donating sperm during and for 90 days after treatment.
  • Female participants must be postmenopausal or surgically sterile.
  • Must be willing to sign an informed consent form before starting the study.

Exclusion Criteria

  • Have received treatment with certain chemotherapy drugs for myelodysplastic syndrome (MDS) or AML.
  • Have acute promyelocytic leukemia.
  • Have active AML involvement in the central nervous system.
  • Have known HIV infection.
  • Have active hepatitis B or C infection, unless the viral load is undetectable.
  • Have received certain cancer treatments within a specified time before starting the study.
  • Have consumed grapefruit, Seville oranges, or star fruit within 3 days before starting the study.
  • Have significant health conditions that could affect participation, such as severe heart failure or uncontrolled infections.
  • Have a history of other cancers, except for certain treated skin cancers or localized cancers.
  • Have a high white blood cell count, unless controlled with hydroxyurea.
  • Are eligible and willing to receive intensive induction therapy.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.