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

Brief Title

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

Official Title

Fludarabine and Cytarabine as Continuous Infusion Plus Idarubicin With Granulocyte-Colony Stimulating Factor (G-CSF) Priming for Patients Younger Than 60 Years With Resistant Acute Myeloid Leukemia

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Complete remission rate, duration of complete remission, toxicities

Secondary Outcome

 progression-free survival, overall survival

Condition

Acute Myeloid Leukemia

Intervention

FLAG+IDA

Study Arms / Comparison Groups

 1

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

37

Start Date

December 2004

Completion Date

June 2008

Eligibility 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
      

Gender

All

Ages

15 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Hawk Kim, professor, 80-2-3010-7290, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT00559221

Organization ID

C-007A

Study Sponsor

Cooperative Study Group A for Hematology

Study Sponsor

Hawk Kim, professor, Principal Investigator, Ulsan Universtity Hospital, ROK

Verification Date

November 2007