Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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 elderly patients with acute myeloid leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Cytarabine; Fludarabine; Fludarabine phosphate; Idarubicin; Vidarabine

Criteria

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