NCT00559221UnknownPhase 2
Fludarabine and Cytarabine as Continuous Infusion Plus Idarubicin With Granulocyte-Colony Stimulating Factor (G-CSF) Priming for Patients Younger Than 60 Years With Resistant Acute Myeloid Leukemia
Cooperative Study Group A for Hematology1 site in 1 country37 target enrollmentStarted: December 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Complete remission rate, duration of complete remission, toxicities
Study Overview
Brief Summary
- To determine the feasibility of fludarabine and cytarabine as continuous infusion plus idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
Detailed Description
- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Failure to achieve CR after initial induction chemotherapy including standard dose cytarabine.
- •Early relapse, occurring after a first CR lasting less than 12 months.
- •Patients with multiple relapses will be included.
- •Written informed consent must be given.
- •15 and 60 years of age.
- •2 or less by ECOG performance scale.
Exclusion Criteria
- •acute promyelocytic leukemia
- •pregnant or lactating
Arms & Interventions
1
No Intervention
Intervention: FLAG+IDA (Drug)
Outcomes
Primary Outcomes
Complete remission rate, duration of complete remission, toxicities
Time Frame: 06/2008
Secondary Outcomes
- progression-free survival, overall survival(06/2008)
Investigators
Study Sites (1)
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