Study on Metronomic Decitabine-Cedazuridine and Venetoclax for Treating Relapsed or High-Risk Blood Cancers

Sponsor: Virginia Commonwealth University

Sponsor score: 0

ClinicalTrials ID:NCT07710534

Provider View

This clinical trial is testing two different treatment combinations to see which is more effective for patients with certain types of relapsed or high-risk blood cancers, including acute myeloid leukemia and myelodysplastic syndromes.

Patient Parameters

Program Overview

This study is exploring two treatment options for patients with specific types of blood cancers that have either returned after treatment or are considered high-risk. Participants will be randomly assigned to receive either a combination of Decitabine-Cedazuridine and Venetoclax or Azacitidine and Venetoclax. The goal is to determine which combination is more effective in controlling the cancer. Treatment will continue until the cancer progresses, side effects become too severe, or the patient undergoes a stem cell transplant.

Description

In this clinical trial, patients with certain types of blood cancers will receive one of two treatment combinations. The first group will receive Decitabine-Cedazuridine and Venetoclax, while the second group will receive Azacitidine and Venetoclax. The study aims to find out which combination works better for treating relapsed or high-risk acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), and high-risk myeloproliferative neoplasms (MPN). Participants will continue treatment until their cancer progresses, they experience unacceptable side effects, or they undergo a stem cell transplant.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with one of the following conditions:
    • Relapsed or refractory acute myeloid leukemia (AML) with certain characteristics.
    • High-risk myelodysplastic syndrome (MDS) based on specific scoring systems.
    • High-risk accelerated-phase myeloproliferative neoplasm (MPN) with certain characteristics.
  • Must have a performance status score between 0 and 3, indicating varying levels of activity.
  • White blood cell count must be below a certain level, with treatment allowed to reduce it if necessary.
  • Liver and kidney function must be within specified limits.
  • Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
  • Participants and their partners must agree to use effective birth control during the study and for three months after the last treatment.

Exclusion Criteria

  • Previous use of both a hypomethylating agent and venetoclax together.
  • Unable to take oral medications or have medical conditions affecting drug absorption.
  • Certain types of leukemia or myeloproliferative neoplasms with specific genetic markers.
  • Significant heart disease or heart failure.
  • Recent treatment with investigational drugs or certain chemotherapies.
  • Allergies to any of the study drugs.
  • Use of other treatments for AML, MDS, or MPN during the study, except for specific allowances.
  • Uncontrolled illnesses or infections, though controlled chronic infections are allowed.
  • Untreated disease affecting the central nervous system.
  • Pregnant or breastfeeding women.
  • Other active cancers requiring treatment that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
Virginia Commonwealth University23298RichmondVirginia

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