FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML

Acute Myeloid Leukemia Clinical Trial

Official title:

Fludarabine and Cytarabine as Continuous Infusion Plus Idarubicin With Granulocyte-Colony Stimulating Factor (G-CSF) Priming for Patients Younger Than 60 Years With Resistant Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00559221
• Other study ID #: C-007A
• Status: Recruiting
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: October 13, 2008
• Start date: December 2004
• Est. completion date: June 2008

Study information

• Verified date: November 2007
• Source: Cooperative Study Group A for Hematology
• Contact: Yae-Eun Jang, nurse
• Phone: 80-2-3010-7290
• Email: redpin75[@]paran.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 idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia

Description:

- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• Failure to achieve CR after initial induction chemotherapy including standard dose cytarabine.

• Early relapse, occurring after a first CR lasting less than 12 months.

• Patients with multiple relapses will be included.

• Written informed consent must be given.

• 15 and 60 years of age.

• 2 or less by ECOG performance scale.

Exclusion Criteria:

• acute promyelocytic leukemia

• pregnant or lactating

Study Design

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• FLAG+IDA
Fludarabine, cytarabine, G-CSF

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	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		06/2008
Secondary	progression-free survival, overall survival		06/2008