Study on Decitabine and Cedazuridine with Venetoclax for Treating Relapsed Acute Myeloid Leukemia After Stem Cell Transplant

Sponsor: Sanjay Mohan

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05799079

Provider View

This clinical trial is exploring a new treatment combination of decitabine, cedazuridine, and venetoclax for patients whose acute myeloid leukemia (AML) has returned after a donor stem cell transplant. The study aims to see if this combination can effectively kill cancer cells and improve patient outcomes.

Patient Parameters

Program Overview

This phase II study is testing how well a combination of decitabine and cedazuridine (DEC-C) with venetoclax works in treating acute myeloid leukemia (AML) that has come back after a donor stem cell transplant. Cedazuridine helps decitabine stay in the body longer, enhancing its effect. Decitabine helps the bone marrow produce normal blood cells and kills abnormal ones. Venetoclax blocks a protein that cancer cells need to survive. Together, these drugs may kill more cancer cells in patients with relapsed AML.

Description

The main goal of this study is to see how well the combination of DEC-C and venetoclax works in achieving complete remission, where the cancer is no longer detectable. Researchers will also look at partial responses, how long patients stay in remission, overall survival rates, and the safety of the treatment.

Participants will take venetoclax by mouth every day for 28 days in a cycle. They will also take DEC-C by mouth daily for the first 5 days of each 28-day cycle. Throughout the study, patients will have bone marrow biopsies and blood tests to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and willing to sign a consent form.
  • Have a confirmed diagnosis of AML that has returned after a donor stem cell transplant.
  • White blood cell count must be below 25,000/ul for at least three days before starting treatment (use of hydroxyurea is allowed).
  • Must have a bone marrow biopsy before joining the trial.
  • Must be in good general health with a performance status score of 0 to 2.
  • Liver enzymes and bilirubin levels must be within specified limits.
  • Kidney function must be adequate, with a creatinine clearance of at least 30 ml/min.
  • Must agree to follow all study requirements, including using contraception and keeping a pill diary.

Exclusion Criteria

  • Have previously relapsed or progressed while on venetoclax or similar drugs.
  • Have received other cancer treatments within two weeks before starting the study, except for hydroxyurea.
  • Have not fully recovered from side effects of previous cancer treatments.
  • Have had a stem cell transplant or similar therapy within three months of joining the study.
  • Have active graft versus host disease (GVHD) or are on certain medications for it.
  • Have had recent radiation therapy or major surgery.
  • Have an uncontrolled infection, unless it is being treated and controlled with antibiotics.
  • Cannot take oral medication or have digestive issues affecting drug absorption.
  • Have active leukemia in the central nervous system.
  • Are taking medications not allowed in the study.
  • Have another cancer that is being treated or will likely need treatment soon, except for certain skin or cervical cancers.
  • Are pregnant or breastfeeding.
  • Have a history of alcohol or drug abuse.
  • Have significant heart disease or recent heart events.
  • Have any other condition that makes participation in the study unsuitable.

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