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

• Sponsor: Cooperative Study Group A for Hematology (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00529880
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Duration (Months): 34
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Fludarabine , cytarabine	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2004
• Anticipated Study Completion Date: Oct 1, 2007

Outcome Measures

Primary Outcome Measures

1. Complete remission rate, duration of complete remission, toxicities []

Secondary Outcome Measures

1. progression-free survival, overall survival []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Songpa-gu	Seoul	Korea, Republic of	138-833

Sponsors and Collaborators

• Cooperative Study Group A for Hematology

Investigators

• Principal Investigator: Hawk Kim, professor, Ulsan University Hospital, ROK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00529880
• Other Study ID Numbers: C-008
• First Posted: Sep 14, 2007
• Last Update Posted: Sep 27, 2007
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: AML
• Additional relevant MeSH terms: Cytarabine; Fludarabine

Study Results

No Results Posted as of Sep 27, 2007