Study on Venetoclax and Azacitidine for Treating Relapsed or Hard-to-Treat High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04550442

Provider View

This clinical trial is exploring the safety and best dose of venetoclax when used with azacitidine to treat patients with high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, venetoclax and azacitidine, to see if they can help control high-risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) that has come back or not responded to treatment. Venetoclax may stop cancer cells from growing by blocking certain enzymes, while azacitidine works by killing cancer cells or stopping them from spreading. The trial aims to find the safest and most effective dose of these drugs when used together.

Description

The main goal of this study is to determine how safe and tolerable the combination of venetoclax and azacitidine is for patients with high-risk MDS or CMML that has returned or not responded to previous treatments. Researchers will also look at how well the treatment works in terms of complete remission, improvement in blood cell counts, and independence from blood transfusions. Other goals include understanding how long patients respond to the treatment, how long they survive without the disease getting worse, and how long it takes before they need another treatment.

The study is divided into two phases. In Phase I, the focus is on finding the safest dose of venetoclax. In Phase II, researchers will evaluate how effective the treatment is. Patients will take venetoclax by mouth daily for 14 days and receive azacitidine through an IV or injection for 5 days. This cycle repeats every 4-8 weeks as long as the disease does not progress and side effects are manageable.

After finishing the treatment, patients will have follow-up visits within 30 days and then every 3-6 months for up to 5 years to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Have high-risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) that has not responded to previous treatments or has returned.
  • Be 18 years or older.
  • Have adequate liver and kidney function based on specific blood tests.
  • Women must not be pregnant and must agree to use effective birth control during the study and for 3 months after the last treatment.
  • Men must agree to use effective birth control during the study and for 3 months after the last treatment.
  • Be in relatively good overall health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Agree to sign a written informed consent document.

Exclusion Criteria

  • Have received any prior treatment with BCL2 inhibitors.
  • Have low or intermediate-1 risk MDS.
  • Have known HIV infection or active hepatitis B or C infection.
  • Have taken certain medications or foods that interact with the study drugs within a specified time before starting the study.
  • Have significant heart, lung, kidney, liver, or other medical conditions that could interfere with the study.
  • Have a history of other cancers within the past 2 years, except for certain non-threatening cancers.
  • Have a white blood cell count higher than 10,000/µL, unless controlled with medication.
  • Have unresolved side effects from previous cancer treatments.
  • Have received a live vaccine within 4 weeks before starting the study.
  • Women who are pregnant or breastfeeding.

Get This Program In Your Inbox

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