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Chemotherapy
Other for Acute Myeloid Leukemia
Phase 1
Waitlist Available
Research Sponsored by Therapeutic Advances in Childhood Leukemia Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during course 1, approx 5 weeks
Awards & highlights
Summary
This trial is testing a new treatment for leukemia that uses decitabine and vorinostat before and during chemotherapy.
Eligible Conditions
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during course 1, approx 5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during course 1, approx 5 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The dose of decitabine that can be safely given with vorinostat, fludarabine, high dose cytarabine and G-CSF (FLAG)
Secondary study objectives
To analyze plasma for cytokine content.
Decitabine
To analyze the correlation between biological changes and clinical response.
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: OtherExperimental Treatment5 Interventions
decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Filgrastim (G-CSF)
1995
Completed Phase 3
~460
Fludarabine
2012
Completed Phase 4
~1860
Cytarabine
2016
Completed Phase 3
~3330
Vorinostat
2014
Completed Phase 3
~1600
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Who is running the clinical trial?
Therapeutic Advances in Childhood Leukemia ConsortiumLead Sponsor
20 Previous Clinical Trials
640 Total Patients Enrolled
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