Study on Venetoclax and Azacitidine for Treating Acute Myeloid Leukemia After Stem Cell Transplant

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04128501

Provider View

This clinical trial is exploring how well the combination of venetoclax and azacitidine works in treating acute myeloid leukemia (AML) after a stem cell transplant. The study aims to see if these drugs can help control high-risk leukemia and prevent it from returning.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, venetoclax and azacitidine, to see if they can effectively treat acute myeloid leukemia (AML) after a stem cell transplant. Venetoclax works by blocking a protein that cancer cells need to survive, while azacitidine is a chemotherapy drug that stops cancer cells from growing and spreading. The goal is to see if this combination can help control leukemia and prevent it from coming back after the transplant.

Description

The main goal of this study is to find out how long patients can stay free of leukemia after receiving venetoclax and azacitidine as maintenance therapy or to eliminate any remaining cancer cells after a stem cell transplant.

The study also aims to:

  • Assess the safety and side effects of the drug combination.
  • Measure how long patients respond to the treatment and their overall survival.
  • Check for any occurrence of graft versus host disease (GVHD), a condition where the donor cells attack the patient's body.
  • Compare the effectiveness of this treatment to standard therapy in patients with no evidence of disease.

Additionally, researchers will explore if certain protein and gene expressions can predict how well patients respond to the treatment.

Participants will receive venetoclax and azacitidine after their stem cell transplant. The treatment involves taking azacitidine by injection and venetoclax by mouth, with cycles repeating every 4-8 weeks for up to 12 cycles, as long as the disease does not progress and side effects are manageable.

Eligibility Criteria

Inclusion Criteria

  • Aged 18 to 75 years.
  • Can speak English or other languages.
  • Diagnosed with certain blood cancers and in remission after a stem cell transplant.
  • Have adequate blood cell counts and organ function.
  • Able to start treatment 42 to 100 days after the transplant.
  • Have used specific conditioning regimens during the transplant.
  • Have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Have normal kidney and liver function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Understand the study and agree to participate.

Exclusion Criteria

  • Have active or uncontrolled graft versus host disease (GVHD).
  • Are using certain immune-suppressing medications.
  • Have active infections or bleeding.
  • Have uncontrolled heart problems or significant heart disease in the past 6 months.
  • Have active viral infections like HIV, Hepatitis B, or Hepatitis C.
  • Have had other cancers unless they have been disease-free for at least 1 year, except for certain skin or cervical cancers.
  • Have cognitive impairments or serious medical or psychiatric conditions that could interfere with the study.

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