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

Phase 2

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: FLAG+IDA

• Registration Number: NCT00559221
• Lead Sponsor: Cooperative Study Group A for Hematology

Brief Summary

- 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

Detailed Description

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

Study Timeline

• Study Start: 2004-12
• Status Verified: 2007-11
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Study Completion: 2008-06
• Last Update Submitted: 2008-10-13
• Last Update Posted: 2008-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	FLAG+IDA	-

Primary Outcome Measures

Name	Time	Method
Complete remission rate, duration of complete remission, toxicities	06/2008

Secondary Outcome Measures

Name	Time	Method
progression-free survival, overall survival	06/2008

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of