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

Study Overview
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Brief Summary
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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
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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).

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Fludarabine , cytarabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fludarabine , cytarabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate, duration of complete remission, toxicities |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival, overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML