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Anti-metabolites

Uproleselan + Cladribine + Cytarabine for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Led By Tapan M Kadia
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a diagnosis of treated secondary-AML (TS-AML) who have not received therapy for their AML will be eligible
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights

Study Summary

This trial is testing a combination of three drugs to treat secondary acute myeloid leukemia. The drugs work in different ways to stop the growth of cancer cells.

Who is the study for?
This trial is for adults over 18 with treated secondary acute myeloid leukemia (TS-AML) who haven't had AML treatment. They should have a stable heart function, normal liver and kidney tests, and no severe allergies to the drugs used. Women must not be pregnant or breastfeeding and all participants must agree to use contraception.Check my eligibility
What is being tested?
The study is testing the combination of Uproleselan, Cladribine, and low dose Cytarabine in patients with TS-AML to find the best doses and see how well they work together in stopping cancer cell growth by killing them or preventing their spread.See study design
What are the potential side effects?
Potential side effects may include reactions related to chemotherapy such as nausea, fatigue, increased risk of infection due to lowered blood counts, liver enzyme changes, potential damage to developing fetuses hence pregnancy exclusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have secondary AML and haven't been treated for it yet.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My AML cancer developed from a previous blood disorder treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Recommended phase II dose
Secondary outcome measures
CR with partial hematologic recovery
CR without blood count recovery (CRi)
Complete response (CR)
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (uproleselan, cladribine, cytarabine)Experimental Treatment3 Interventions
INDUCTION THERAPY: Patients receive uproleselan IV over 20 minutes on day 1 and Q 12 hours on days 2-12, cladribine IV over 1-2 hours on days 1-5 and cytarabine SC BID on days 1-10 in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR or CRi after cycle 1 may receive a second induction cycle. CONSOLIDATION/MAINTENANCE THERAPY: Patients receive uproleselan IV over 20 minutes on day 1 and Q12 hours on days 2-1. Patients who have achieved at least CR/CRi or morphologic leukemia-free state after induction therapy receive uproleselan IV QD on days 1-12. Patients also receive cladribine IV over 1-2 hours on days 1-3 and cytarabine SC BID on days 1-10. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine
FDA approved
Uproleselan
Not yet FDA approved
Cytarabine
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,798,198 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,226 Total Patients Enrolled

Media Library

Cladribine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04848974 — Phase 1 & 2
Cladribine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04848974 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Treatment (uproleselan, cladribine, cytarabine)
Acute Myeloid Leukemia Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT04848974 — Phase 1 & 2
~17 spots leftby Dec 2026
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