Cladribine + Cytarabine vs. HMA + Venetoclax for Acute Myeloid Leukemia

Overseen By Judy Walsh

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Hypomethylating agents

Disqualifiers: APML, CNS leukemia, severe kidney impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

Trial Summary

What is the purpose of this 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).

Research Team

Paul Crispen, MD

Principal Investigator

University of Florida

Eligibility Criteria

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

I am 60 years old or older.

I have AML or high grade MDS without prior treatment, excluding APL.

My kidneys are working well.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either cladribine/low-dose cytarabine alternating with decitabine or hypomethylating agents plus venetoclax

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Cladribine
• Cytarabine
• Decitabine
• Venetoclax

Trial Overview The study compares a new treatment combo of Cladribine/LoDAC with Decitabine against the standard Hypomethylating Agents plus Venetoclax in elderly/unfit patients with AML/MDS. Patients will randomly receive either the novel regimen (Arm A) or the current standard care (Arm B).

Participant Groups

Group I: Arm A (investigational arm): cladribine, cytarabine, and decitabine Experimental Treatment 3 Interventions

Group II: Arm B (control arm): azacitidine with venetoclax or decitabine with venetoclax Active Control 2 Interventions

Cladribine is already approved in United States, European Union for the following indications:

Approved in United States as Leustatin for:

• Hairy cell leukemia
• Chronic lymphocytic leukemia (CLL)
• Non-Hodgkin's lymphoma
• Multiple sclerosis

Approved in European Union as Litak for:

• Hairy cell leukemia
• Chronic lymphocytic leukemia (CLL)
• Non-Hodgkin's lymphoma

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+