Study on Venetoclax to Improve Outcomes of Chemotherapy in Patients with High-Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04708054

Provider View

This clinical trial is exploring whether adding the drug venetoclax to a standard chemotherapy regimen can improve outcomes for patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are undergoing stem cell transplants.

Patient Parameters

Program Overview

This study is testing if adding venetoclax to a combination of chemotherapy drugs—busulfan, cladribine, and fludarabine—can help control high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in patients receiving stem cell transplants. These chemotherapy drugs work by stopping cancer cells from growing, dividing, or spreading. The study aims to see if this new combination can improve patient outcomes.

Description

The study is divided into two phases:

Phase II

  • The main goal is to gather early evidence on how well the treatment works, measured by how long patients live without the disease getting worse over one year.
  • Other goals include assessing the safety of the treatment, how quickly blood cells recover after treatment, the occurrence of graft-versus-host disease (GVHD), relapse rates, survival rates, and overall survival without relapse or GVHD.

Phase III

  • The main goal is to compare the effectiveness of the new treatment (venetoclax with busulfan, cladribine, and fludarabine) against the standard treatment (fludarabine and busulfan) in terms of progression-free survival.
  • Other goals include comparing safety, blood cell recovery time, GVHD occurrence, relapse rates, non-relapse mortality, overall survival, and survival without relapse or GVHD between the two treatment groups.

Eligibility Criteria

Inclusion Criteria

Phase II

  • Adults aged 18 to 70 years.
  • Diagnosed with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with specific risk factors.
  • Must have a suitable stem cell donor.
  • Must sign an informed consent form.
  • Women of childbearing potential must test negative for pregnancy.
  • Must have adequate liver and kidney function.

Phase III

  • Adults aged 18 to 65 years.
  • Diagnosed with high-risk AML or MDS with specific risk factors.
  • Must have a suitable stem cell donor.
  • Must sign an informed consent form.
  • Women of childbearing potential must test negative for pregnancy.
  • Must have adequate liver and kidney function.

Exclusion Criteria

  • Positive for HIV.
  • Cognitive impairments or being a prisoner.
  • Diagnosed with acute promyelocytic leukemia.
  • Active central nervous system involvement with AML.
  • Uncontrolled infections or chronic hepatitis B or C requiring treatment.
  • Heart problems requiring treatment or low heart function.
  • Lung function below certain levels.
  • Consumption of grapefruit, Seville oranges, or star fruit within 3 days before starting the study.
  • Previous use of certain cancer drugs (gemtuzumab ozogamicin or inotuzumab ozogamicin).
  • Previous stem cell transplant.

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