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

• Status: Unknown status
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cooperative Study Group A for Hematology
• Treatments: Cytarabine; Fludarabine; Fludarabine phosphate

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