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

Phase 2

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT00529880
• Lead Sponsor: Cooperative Study Group A for Hematology

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).

Study Timeline

• Study Start: 2004-12
• Status Verified: 2007-09
• Study First Submitted: 2007-09-12
• Study First Submitted QC: 2007-09-12
• Study First Posted: 2007-09-14
• Last Update Submitted: 2007-09-26
• Last Update Posted: 2007-09-27
• Study Completion: 2007-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complete remission rate, duration of complete remission, toxicities

Secondary Outcome Measures

Name	Time	Method
progression-free survival, overall survival

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Songpa-gu, Seoul, Korea, Republic of