Study on Venetoclax with Decitabine and Cedazuridine for Treating Relapsed or Hard-to-Treat Acute Myeloid Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04975919

Provider View

This clinical trial is exploring a combination of drugs, including venetoclax, decitabine, and cedazuridine, to treat patients with acute myeloid leukemia (AML) that has returned or is not responding to treatment. The study aims to see if this combination can help control the disease.

Patient Parameters

Program Overview

This study is testing a combination of three drugs—venetoclax, decitabine, and cedazuridine—to treat patients with acute myeloid leukemia (AML) that has either come back after treatment or is not responding to current treatments. Venetoclax and decitabine are chemotherapy drugs that work by stopping cancer cells from growing and spreading. Cedazuridine helps by blocking certain enzymes needed for cancer cell growth. The goal is to see if this combination can effectively control AML.

Description

The main goal of this study is to find out how well the combination of venetoclax, decitabine, and cedazuridine works in treating patients with relapsed or refractory acute myeloid leukemia (AML). Researchers will look at how many patients achieve a complete or partial response to the treatment. They will also study how long these responses last, how long patients live without the disease getting worse, and overall survival rates.

The study will also assess the safety of the treatment and how many patients can move on to stem cell transplantation after responding to the therapy. Additionally, researchers will monitor for any infections that occur during treatment cycles.

Participants will take decitabine and cedazuridine by mouth once a day for 10 days. If they achieve a complete response, they may continue with a shorter course of these drugs. Venetoclax will be taken daily for the first 28 days of the first cycle and then for 21 days in the following cycles. Each treatment cycle lasts 28 days, and patients will continue treatment as long as it is effective and safe.

After finishing the study treatment, patients will have follow-up visits every three months to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or refractory acute myeloid leukemia (AML) or similar types of leukemia.
  • Age 18 years or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Kidney function with creatinine levels below 2, unless related to the disease.
  • Liver function with bilirubin levels below 2 times the upper limit of normal, unless due to specific conditions.
  • Liver enzymes (AST/ALT) below 3 times the upper limit of normal, unless due to leukemia.
  • At least 7 days since last treatment for leukemia, unless rapid disease progression requires earlier treatment.
  • Male participants must agree to use contraception and avoid sperm donation during and after treatment.
  • Willing to provide informed consent.

Exclusion Criteria

  • Have a specific type of leukemia called acute promyelocytic leukemia (APL).
  • Have active graft-versus-host disease after a stem cell transplant.
  • Have severe digestive or metabolic issues affecting medication absorption.
  • Have active or poorly controlled central nervous system (CNS) leukemia.
  • Have uncontrolled health conditions, such as infections, high blood pressure, heart failure, or arrhythmias.
  • Have active hepatitis B or C, or HIV infection.
  • Have a high white blood cell count over 10 x 10^9/L (can use hydroxyurea to lower it).
  • Have any condition that may interfere with study participation or safety.
  • Are pregnant, breastfeeding, or not using effective contraception if of childbearing potential.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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