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

  • participants needed
  • sponsor
    Cooperative Study Group A for Hematology
Updated on 22 January 2022
granulocyte colony stimulating factor
cell transplantation
induction chemotherapy
acute promyelocytic leukemia
colony stimulating factor


- 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.


- 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).

Condition Acute Myeloid Leukemia
Treatment Fludarabine , cytarabine
Clinical Study IdentifierNCT00529880
SponsorCooperative Study Group A for Hematology
Last Modified on22 January 2022

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