Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant AML

Brief Title

Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant AML

Brief Summary

      -  To determine the feasibility of fludarabine and cytarabine as continuous infusion plus
           granulocyte-colony stimulating factor priming for elderly 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.

Detailed Description

      -  A second course of induction chemotherapy can be given to the patient when a partial
           remission but less than a complete remission is achieved after the first course. At
           least 4 weeks should be apart between start of the first course and start of the second
           course.

        -  G-CSF (Lenograstim) 250 g/day will begin to be administered after the confirmation of
           hypocellular bone marrow with blasts less than 5% on day 14 or later until absolute
           neutrophil counts are 1,000/l or more.

        -  For the patients who achieve a complete remission, consolidation therapy will be given
           as follows:

             -  Two more cycles of the same chemotherapy will be given to the patients who achieve
                a complete remission after single induction course. Allogeneic or autologous
                hematopoietic cell transplantation could be also considered.

             -  In patients who relapse after allogeneic hematopoietic cell transplantation, donor
                leukocyte infusion will be done without consolidation chemotherapy.

             -  In patients who had extramedullary relapse(s), local radiotherapy can be given to
                the relapse site(s).

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

Fludarabine , cytarabine

Publications

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

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

December 2004

Completion Date

October 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Failure to achieve CR after initial induction chemotherapy

          -  Any relapse, regardless of the frequency and time of relapse from first CR

          -  Relapse after hematopoietic cell transplantation, allogeneic or autologous.

          -  Multiple relapses, extramedullary relapse(s)

        Exclusion Criteria:

          -  Inadequate hepatic,renal,cardiac function

          -  Psychiatric disorder or mental deficiency

          -  CNS involvement of leukemic blasts

Gender

All

Ages

60 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Hawk Kim, professor, 82-2-3010-7290, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations

NCT ID

NCT00529880

Organization ID

C-008

Study Sponsor

Cooperative Study Group A for Hematology

Study Sponsor

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

Verification Date

September 2007