NCT00529880

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Cooperative Study Group A for Hematology · Network
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Fludarabine , cytarabine

Timeline

• Start date: 2004-12-01
• Completion: 2007-10-01
• First posted: 2007-09-14
• Last updated: 2007-09-27

Locations

1 site across 1 country: South Korea