Cladribine + Cytarabine vs. HMA + Venetoclax for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatment plans for individuals with acute myeloid leukemia (AML) or severe myelodysplastic syndrome (MDS), particularly those who may not tolerate intense treatments. One plan combines cladribine (a chemotherapy drug), cytarabine, and decitabine. The other uses azacitidine or decitabine with venetoclax, the current standard treatment. The trial aims to determine which treatment is more effective. It is suitable for those diagnosed with AML or high-grade MDS who experience symptoms such as frequent blood transfusions, significant weight loss, or night sweats. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get specific guidance based on your situation.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of cladribine, low-dose cytarabine, and decitabine is generally well-tolerated by patients. Studies have found this treatment safe and effective for certain blood cancers. For instance, one study reported a 68% positive response rate in patients unable to undergo more intense treatments.
Cladribine's FDA approval for other uses supports its safety. While some side effects occurred, they were manageable, and the treatment was deemed safe.
Participants should understand that this trial phase focuses on collecting more detailed information about safety and effectiveness. So far, the treatment has shown promising safety results.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for Acute Myeloid Leukemia (AML) because they combine innovative approaches that differ from the standard care. Unlike most AML treatments that typically use hypomethylating agents like azacitidine or decitabine with venetoclax, the investigational treatment includes cladribine and cytarabine, which target cancer cells in a unique way. Cladribine and cytarabine disrupt DNA synthesis differently, which can potentially enhance the effectiveness against leukemia cells. This combination may offer new hope for patients by possibly improving treatment outcomes compared to existing options.
What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?
Research has shown that a combination of three drugs—cladribine, low-dose cytarabine, and decitabine—may be promising for treating acute myeloid leukemia (AML). Participants in the investigational arm of this trial will receive this combination. In earlier studies, this treatment led to a high response rate of 68% in patients unable to handle intensive treatment. Another study found that 93% of newly diagnosed AML patients showed no signs of cancer after treatment. These results suggest that this treatment could be effective for AML, particularly for patients who cannot undergo more aggressive therapies.12356
Who Is on the Research Team?
Paul Crispen, MD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for patients aged 60 or older with acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS), who are unfit for intensive induction. It's also open to younger patients if they prefer a non-intensive regimen. Participants must be treatment-naive, have an ECOG Performance status of 0-2, and adequate kidney function. Prior HMA therapy is okay unless it led to AML progression.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either cladribine/low-dose cytarabine alternating with decitabine or hypomethylating agents plus venetoclax
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Cladribine
- Cytarabine
- Decitabine
- Venetoclax
Cladribine is already approved in United States, European Union for the following indications:
- Hairy cell leukemia
- Chronic lymphocytic leukemia (CLL)
- Non-Hodgkin's lymphoma
- Multiple sclerosis
- Hairy cell leukemia
- Chronic lymphocytic leukemia (CLL)
- Non-Hodgkin's lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor