FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML

Cooperative Study Group A for Hematology37 enrolled

Overview

\- 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

\- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

FLAG+IDADRUG

Fludarabine, cytarabine, G-CSF

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Complete remission rate, duration of complete remission, toxicities

Time frame: 06/2008

Secondary Outcomes

progression-free survival, overall survival

Time frame: 06/2008

Central Contacts

Yae-Eun Jang, nurse

CONTACT

80-2-3010-7290 redpin75@paran.com

Data from ClinicalTrials.gov

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