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

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: induction chemotherapy (fludarabine, cytarabine, idarubicin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01247493

H-0704-029-205

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)