Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia)
Phase 2
60 Years
N/A
60 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia
Both
Acute Myeloid Leukemia
Trial Information
Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia)
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete remission rate
Outcome Description:
Rate of complete remssion (CR) after two cycles of m-FLAI induction
Safety Issue:
No
Principal Investigator
Inho Kim
Investigator Role:
Principal Investigator
Investigator Affiliation:
professor
Authority:
South Korea: Institutional Review Board
Study ID:
H-0704-029-205
NCT ID:
NCT01247493
Start Date:
June 2007
Completion Date:
July 2010
Related Keywords:
- Acute Myeloid Leukemia
- fludarabine
- AML
- Efficacy
- tolerability
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|
