Study on Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine for Treating Untreated Acute Myeloid Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03586609

Provider View

This clinical trial is testing a combination of drugs to see how well they work in treating patients with acute myeloid leukemia (AML) who have not received any prior treatment. The study aims to find out if this combination can effectively stop the growth of cancer cells.

Patient Parameters

Program Overview

This study is exploring how well a combination of drugs—venetoclax, cladribine, low dose cytarabine, and azacitidine—works in treating patients with acute myeloid leukemia (AML) who have not been treated before. These drugs work in different ways to stop cancer cells from growing, dividing, or spreading. The treatment involves an initial phase (induction) followed by a maintenance phase (consolidation) to see if it can improve outcomes for patients with AML.

Description

The main goal of this study is to see how many patients with acute myeloid leukemia (AML) achieve a complete response (CR) or a complete response with incomplete recovery (CRi) when treated with a combination of venetoclax, cladribine, low-dose cytarabine, and azacitidine.

Secondary goals include assessing overall survival, disease-free survival, and the overall response rate of patients treated with this combination. The study will also look at the safety and any side effects of the treatment.

The study will also explore how the body processes venetoclax when taken with other drugs and how this affects the treatment's effectiveness and side effects. Researchers will also examine genetic factors that might influence how well patients respond to the treatment.

Treatment Plan:

  • Induction Phase: Patients will receive cladribine through an IV for 1-2 hours daily for 5 days, cytarabine as an injection twice daily for 10 days, and venetoclax as a pill daily for 21 days. This cycle lasts 28 days. If the cancer does not respond after the first cycle, a second cycle may be given.

  • Consolidation/Maintenance Phase: Patients who respond to the first cycle will continue with cladribine, cytarabine, and venetoclax, along with azacitidine, in cycles lasting 28 days each, for up to 18 cycles.

After completing the treatment, patients will have follow-up visits every 6-12 months for up to 5 years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Have been diagnosed with acute myeloid leukemia (AML) and have not received treatment for it before. Some previous treatments for stabilization are allowed.
  • Be 50 years or older. Patients under 50 may be eligible if they cannot undergo standard treatment.
  • Have adequate liver and kidney function based on specific blood test results.
  • Have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.
  • Must understand the study requirements and sign an informed consent form before participating.

Exclusion Criteria

  • Women who are pregnant or breastfeeding due to potential risks to the baby.
  • Have uncontrolled illnesses such as infections, heart problems, or psychiatric conditions that could interfere with the study.
  • Have allergies to any of the study drugs.
  • Men and women of childbearing potential who do not agree to use contraception during the study.
  • Have previously been treated with venetoclax.
  • Have a specific type of leukemia called acute promyelocytic leukemia (AML-M3).

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.