Comparing Different Drug Combinations for Treating Younger Patients with Intermediate Risk Acute Myeloid Leukemia (AML)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05554393

Provider View

This clinical trial is testing three different drug combinations to find the most effective treatment for younger patients with intermediate risk acute myeloid leukemia (AML). The study aims to see if adding the drug venetoclax to standard treatments can improve outcomes.

Patient Parameters

Program Overview

This study is comparing three different treatment combinations for younger patients with intermediate risk acute myeloid leukemia (AML). The treatments being tested are: cytarabine with daunorubicin, cytarabine with daunorubicin and venetoclax, and venetoclax with azacitidine. The goal is to see if adding venetoclax can help eliminate AML more effectively than the standard treatment of cytarabine and daunorubicin alone. Researchers are looking to see if venetoclax can increase the rate of AML elimination by 20% or more compared to the usual approach.

Description

The main goal of this study is to compare how well each treatment combination works in achieving complete remission, where no measurable disease is detected, in patients with AML. The study will also look at the side effects of each treatment and how long patients remain free of disease after treatment.

Patients will be randomly assigned to one of three treatment groups:

  • Group 1: Patients receive daunorubicin and cytarabine, along with venetoclax. Treatment cycles last 28 days and may be repeated if needed.
  • Group 2: Patients receive azacitidine and venetoclax. Treatment cycles last 28 days and are repeated for a total of two cycles.
  • Group 3: Patients receive daunorubicin and cytarabine. Treatment cycles last 28 days and may be repeated if needed.

Throughout the study, patients will have regular bone marrow tests and blood samples taken to monitor their response to treatment. After completing the study treatment, patients will have follow-up visits to check their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in the MyeloMATCH program and assigned to this trial based on specific genetic findings.
  • Must have untreated acute myeloid leukemia (AML) with more than 20% myeloblasts in the blood or bone marrow, excluding certain genetic types of AML.
  • Must be between 18 and 59 years old.
  • Must have a performance status score of 3 or less, indicating they are able to carry out daily activities with some limitations.
  • Must have adequate liver, kidney, and heart function as shown by specific medical tests.
  • Must have a white blood cell count below 25 x 10^9/L before starting treatment.
  • Must agree to use effective birth control during and for six months after treatment.
  • Must be willing to provide informed consent and be available for follow-up visits.
  • Must not be taking certain medications that interact with the study drugs.
  • Must have controlled HIV, hepatitis B, or hepatitis C infections if applicable.

Exclusion Criteria

  • Have received prior treatment for AML, except for hydroxyurea or leukapheresis to control blood counts.
  • Are taking other investigational drugs.
  • Have a history of allergic reactions to similar drugs used in the study.
  • Are pregnant or breastfeeding, due to potential risks to the baby.
  • Have isolated myeloid sarcoma.
  • Have any serious illness or medical condition that could compromise safety during the study.

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