Acute Myeloid Leukemia
Conditions
Keywords
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).
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate, duration of complete remission, toxicities | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, overall survival | — |
Countries
South Korea