FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
AML
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: FLAG+IDA
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 15 Years
Gender: Both
Criteria: 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
Location
Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Yae-Eun , Jang - 82-2-3010-7290 - redpin75@paran.com
Start Date
December 2004
Completion Date
June 2008
Sponsors
Cooperative Study Group A for Hematology
Source
Cooperative Study Group A for Hematology
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page