Study of Venetoclax and Azacitidine for Untreated Acute Myeloid Leukemia Patients Ineligible for Standard Therapy

Sponsor: AbbVie

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02993523

Provider View

This clinical trial is testing whether adding the drug venetoclax to azacitidine is more effective than azacitidine alone for treating patients with Acute Myeloid Leukemia (AML) who cannot undergo standard intensive treatment.

Patient Parameters

Program Overview

Acute Myeloid Leukemia (AML) is a fast-growing cancer affecting certain white blood cells. This study aims to find out if combining venetoclax, a drug that targets cancer cells, with azacitidine is more effective than using azacitidine alone. The trial is for patients aged 18 and older who have not received prior treatment and are not suitable for standard intensive therapy. Participants will be randomly assigned to receive either the combination of venetoclax and azacitidine or azacitidine with a placebo. The study will monitor the effects of the treatment through blood tests, bone marrow exams, scans, and health questionnaires.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of Acute Myeloid Leukemia (AML) and have not been treated before.
  • Must be 18 years or older.
  • Must have a life expectancy of at least 12 weeks.
  • Must be ineligible for standard intensive therapy due to age (75 years or older) or other health conditions such as heart or lung issues, or liver or kidney problems.
  • Must have a performance status score indicating they are able to carry out light activities.
  • Must have adequate kidney and liver function based on specific blood tests.
  • Women must be postmenopausal, surgically sterile, or using effective birth control. Men must agree to use contraception and not donate sperm during the study.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Must agree to sign an informed consent form.

Exclusion Criteria

  • Have received previous treatment for Myelodysplastic Syndrome (MDS) or AML.
  • Have participated in other research studies or received experimental therapies for MDS or AML.
  • Have certain genetic markers or types of leukemia that are not included in this study.
  • Have active central nervous system involvement with AML.
  • Have HIV or active hepatitis B or C infections.
  • Have taken certain medications or foods that interact with the study drugs shortly before starting the trial.
  • Have significant heart, lung, kidney, liver, or other medical conditions that could interfere with the study.
  • Have a history of other cancers within the last two years, except for certain skin cancers or other localized cancers that have been treated successfully.
  • Have a high white blood cell count, unless treated to lower it before starting the study.

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