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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00529880
Enrollment
19
Registered
2007-09-14
Start date
2004-12-31
Completion date
2007-10-31
Last updated
2007-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

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).

Interventions

DRUGFludarabine , cytarabine

Sponsors

Cooperative Study Group A for Hematology
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Complete remission rate, duration of complete remission, toxicities

Secondary

MeasureTime frame
progression-free survival, overall survival

Countries

South Korea

Contacts

Primary ContactKeun-Hee Kim, nurse
kuny9847@naver.com82-2-3010-7290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026