Cladribine with Low-Dose Cytarabine

Phase II Prospective Randomized Control Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction

What's the purpose of the trial?

This phase II, open-label, randomized trial will compare the efficacy of the novel regimen of cladribine/low-dose cytarabine alternating with decitabine to the current standard of care regimen of hypomethylating agents (decitabine or azacitidine) plus venetoclax in patients with acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS) who are either elderly or unfit for intensive induction. Subjects will be randomized to be treated with either cladribine/low-dose cytarabine alternating with decitabine (Arm A) or decitabine or azacitadine plus venetoclax (Arm B).
Trial status

Not yet accepting

Phase
Phase 2
Enrollment
98
Last Updated
1 week ago
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Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Azacitidine is a type of chemotherapy called a hypomethylating agent that interferes with the growth and spread of cancer cells in the body. 
  • Cladribine is a chemotherapy medication approved for use in hairy cell leukemia, B-cell chronic lymphocytic leukemia, and multiple sclerosis. 
  • Cytarabine is an antineoplastic chemotherapy agent that is FDA approved to treat several different kinds of leukemia.
  • Decitabine is a type of chemotherapy called a hypomethylating agent that interferes with the growth and spread of cancer cells in the body. 
  • Venetoclax is a BCL-2 inhibitor that may work by blocking the action of the BCL-2 protein on some cancer cells which can lead to cell death. 

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