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

Acute Myeloid Leukemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00529880
• Other study ID #: C-008
• Status: Recruiting
• Phase: Phase 2
• First received: September 12, 2007
• Last updated: September 26, 2007
• Start date: December 2004
• Est. completion date: October 2007

Study information

• Verified date: September 2007
• Source: Cooperative Study Group A for Hematology
• Contact: Keun-Hee Kim, nurse
• Phone: 82-2-3010-7290
• Email: kuny9847[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Fludarabine , cytarabine

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Songpa-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Study Group A for Hematology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission rate, duration of complete remission, toxicities
Secondary	progression-free survival, overall survival