Last updated on September 2007

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

Brief description of study

- 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 Study 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).

Clinical Study Identifier: NCT00529880

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Keun-Hee Kim, nurse

Asan Medical Center
Songpa-gu, Korea, Republic of
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