Brief Title
Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant 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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Complete remission rate, duration of complete remission, toxicities
Secondary Outcome
progression-free survival, overall survival
Condition
Acute Myeloid Leukemia
Intervention
Fludarabine , cytarabine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
19
Start Date
December 2004
Completion Date
October 2007
Eligibility 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
Gender
All
Ages
60 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Hawk Kim, professor, 82-2-3010-7290, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT00529880
Organization ID
C-008
Study Sponsor
Cooperative Study Group A for Hematology
Study Sponsor
Hawk Kim, professor, Principal Investigator, Ulsan University Hospital, ROK
Verification Date
September 2007