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Anti-metabolites

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

Phase 2
Waitlist Available
Led By Paul Crispen, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 60 years.
Participants must have a diagnosis of treatment-naive AML (excluding acute promyelocytic leukemia [APL]) or high grade MDS defined as >10% marrow blasts or R-IPSS of intermediate 2 risk or higher.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new treatment for patients with acute myeloid leukemia or high-grade myelodysplastic syndrome who are elderly or unable to undergo intensive treatment. The trial will compare the

Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
Potential side effects may include nausea, fatigue, low blood counts leading to increased infection risk, bleeding complications, liver and kidney abnormalities. Specific side effects depend on which treatment arm the patient is in.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I have AML or high grade MDS without prior treatment, excluding APL.
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My kidneys are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of complete remission
Secondary study objectives
Event-free survival
Overall response rate
Overall survival
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (investigational arm): cladribine, cytarabine, and decitabineExperimental Treatment3 Interventions
Group II: Arm B (control arm): azacitidine with venetoclax or decitabine with venetoclaxActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine
2014
Completed Phase 4
~4410
Cytarabine
2016
Completed Phase 3
~3330
Decitabine
2004
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,393 Previous Clinical Trials
766,926 Total Patients Enrolled
Paul Crispen, MDPrincipal InvestigatorUniversity of Florida
3 Previous Clinical Trials
280 Total Patients Enrolled
Zeina Al-Mansour, MDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
5 Total Patients Enrolled
~65 spots leftby Dec 2029
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