Study Comparing Cladribine and Low-Dose Cytarabine with Decitabine vs. Standard Treatment for AML or High-Grade MDS in Patients Unable to Undergo Intensive Therapy

Sponsor: University of Florida

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05766514

Provider View

This clinical trial is testing two different treatment approaches for patients with acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS) who are not suitable for intensive therapy. The study compares a new combination of cladribine and low-dose cytarabine with decitabine against the current standard treatment of hypomethylating agents plus venetoclax.

Patient Parameters

Program Overview

This study aims to find out which treatment is more effective for patients with acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS) who cannot undergo intensive therapy. Participants will be randomly assigned to receive either a new combination of cladribine and low-dose cytarabine alternating with decitabine, or the standard treatment of hypomethylating agents (decitabine or azacitidine) plus venetoclax. The trial is open-label, meaning both the researchers and participants know which treatment is being given.

Eligibility Criteria

Inclusion Criteria

  • Age over 60 years, or under 60 if not fit for intensive therapy.
  • Newly diagnosed with AML (except acute promyelocytic leukemia) or high-grade MDS with specific conditions like more than 10% bone marrow blasts.
  • Conditions such as rapidly declining blood counts, transfusion dependence, or certain genetic changes that increase risk.
  • White blood cell count less than 25,000/uL (can be reduced with medication before joining).
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 4 months after.
  • Men with partners of childbearing potential must agree to use contraception during the study and for 4 months after.

Exclusion Criteria

  • Have acute promyelocytic leukemia (APL).
  • Have active leukemia in the central nervous system.
  • Poor overall health with a performance status below 50, unless related to AML/MDS.
  • Have AML with specific genetic mutations that have approved targeted therapies.
  • Have inherited conditions like Fanconi Anemia.
  • Have severe kidney or heart problems, or advanced liver disease.
  • Have active viral infections like HIV, hepatitis B, or hepatitis C unless fully treated.
  • Have uncontrolled infections or a history of severe allergic reactions to study drugs.
  • Have had another active cancer requiring treatment in the past 2 years.
  • Are prisoners or involuntarily detained.
  • Have psychiatric or substance abuse issues that would interfere with the study.

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