Status:
COMPLETED
Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)
Lead Sponsor:
Seoul National University Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
A phase II clinical trial evaluating the efficacy and tolerability of induction and consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin (modified-FLAI) in the ...
Eligibility Criteria
Inclusion
- previously untreated AML (excluding acute promyelocytic leukemia)
- age greater than 60 years old
- ECOG PS (Eastern Cooperative Oncology Group Performance scale) less than 2
- adequate hepatic/ renal/ cardiac function
Exclusion
- acute promyelocytic leukemia
- significant cardiac disease
- combined non-hematologic malignancy
- aleukemic leukemia (only granulocytic sarcoma)
- CNS (Central Nervous system) involvement
- significant comorbidity/ uncontrollable bleeding tendency
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01247493
Start Date
June 1 2007
End Date
July 1 2010
Last Update
November 24 2010
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea