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Anti-metabolites

Fludarabine for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults 18 years of age or older
ECOG performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will test a new combination of drugs for people with a certain type of leukemia. The drugs will be given during treatment and for 2 cycles after treatment.

Eligible Conditions
  • Acute Myeloid Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Overall response rate after induction
Secondary outcome measures
30-day
60-day mortality
CR Rate
+9 more
Other outcome measures
Descriptive Statistics of Patients Mutation Profile at Relapse
Descriptive Statistics of Patients Mutation Profile at Screening
Neoplasm, Residual

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837
36%
Infection (grade 3 and above)
24%
Graft versus host disease
8%
Renal insufficiency
4%
SupraVentricular Tachycardia
4%
Alerted mental status
4%
Posterior Reversible Encephalopathy Syndrome
4%
Gastrointestinal bleed
4%
Respiratory failure
4%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients With Sickle Cell Anemia

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fludarabine and CPX351Experimental Treatment2 Interventions
Induction 1: Fludarabine 30 mg/m2/day IV on days 1-5 for 5 doses Daunorubicin and cytarabine liposome (CPX-351) daunorubicin 44 mg/m2/day and cytarabine 100 mg/m2/day IV on days 1, 3, 5 (given 4 hours after fludarabine infusion) for 3 doses Induction 2 (residual leukemia after Induction 1): Fludarabine 30 mg/m2/day IV on days 1-3 for 3 doses Daunorubicin and cytarabine liposome (CPX-351) daunorubicin 44 mg/m2/day and cytarabine 100 mg/m2/day IV on days 1, 3 (given 4 hours after fludarabine infusion) for 2 doses Optional consolidation, up to 2 cycles: Daunorubicin and cytarabine liposome (CPX-351) daunorubicin 29 mg/m2/day and cytarabine 65 mg/m2/day IV on days 1, 3 for 2 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,405 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,357 Total Patients Enrolled
Matthew Wieduwilt, MD, PhD3.816 ReviewsStudy Chair - UC San Diego
University of California, San Diego
5Patient Review
My husband's life has been saved by this doctor on not one, but two occasions. We would travel 6,000 miles to see him again. Paula, Anchorage

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.
James Mangan 2020. "Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04425655.
~0 spots leftby Apr 2025
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