Study Comparing Venetoclax and Azacitidine with Standard Chemotherapy in Acute Myeloid Leukemia (AML)

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04801797

Provider View

This clinical trial is testing a new combination of drugs, venetoclax and azacitidine, against the standard chemotherapy treatment for patients with acute myeloid leukemia (AML) who are eligible for intensive treatment.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of a new drug combination, venetoclax and azacitidine, with the standard chemotherapy treatment for patients with acute myeloid leukemia (AML). The study will involve two groups: one receiving the new combination and the other receiving standard chemotherapy drugs like cytarabine and idarubicin or daunorubicin. The goal is to see which treatment works better in controlling AML.

Description

This study is a phase II clinical trial that will compare two treatment options for adults with newly diagnosed acute myeloid leukemia (AML) who are fit for intensive treatment. One group will receive the standard chemotherapy regimen, which includes drugs like cytarabine and idarubicin or daunorubicin. The other group will receive a combination of venetoclax and azacitidine, which is a newer treatment option.

The U.S. Food and Drug Administration (FDA) has approved the standard chemotherapy drugs for treating AML. The combination of venetoclax and azacitidine is also approved for older patients or those with other health issues that prevent them from receiving intensive chemotherapy.

Venetoclax works by targeting a protein that helps cancer cells survive, while azacitidine helps kill rapidly dividing cancer cells. The study will involve screening for eligibility, receiving the study treatment, and attending follow-up visits.

Participants will continue the treatment as long as it is beneficial, and they will be monitored for up to three years. Approximately 172 people are expected to participate in this study, which is supported by AbbVie, a biopharmaceutical company.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of acute myeloid leukemia (AML) with 20% or more cancer cells in the blood or bone marrow.
  • Eligible for intensive chemotherapy according to their doctor.
  • Have a good performance status, meaning they can carry out daily activities with minimal assistance.
  • Have a heart function greater than 50%.
  • Have not received prior treatment for AML, except for certain medications to reduce white blood cell count.
  • Have adequate kidney and liver function based on specific blood tests.
  • Agree to use effective birth control during the study and for a period after the study.
  • Able to understand and sign a consent form to participate in the study.

Exclusion Criteria

  • Have a specific type of leukemia called acute promyelocytic leukemia (APL) or AML with certain genetic features.
  • Have a known genetic mutation called FLT3, unless it is at a very low level.
  • Have a different type of leukemia or a mixed type.
  • Have taken certain medications or foods that affect the study drugs within a specified time before starting the study.
  • Have received prior chemotherapy or radiation for AML, except for certain allowed medications.
  • Have a history of another cancer unless it has been in remission for at least three years.
  • Have active infections or other serious medical conditions.
  • Have a history of heart failure or other heart problems.
  • Are pregnant or breastfeeding.
  • Have psychological or social factors that would prevent them from following the study requirements.

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