Back to resultsFLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML
Primary Purpose
Acute Myeloid Leukemia
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FLAG+IDA
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML
Eligibility Criteria
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
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Complete remission rate, duration of complete remission, toxicities
Secondary Outcome Measures
progression-free survival, overall survival
Full Information
NCT ID
NCT00559221
First Posted
November 15, 2007
Last Updated
October 13, 2008
Sponsor
Cooperative Study Group A for Hematology
1. Study Identification
Unique Protocol Identification Number
NCT00559221
Brief Title
FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Cooperative Study Group A for Hematology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed Description
- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
FLAG+IDA
Intervention Description
Fludarabine, cytarabine, G-CSF
Primary Outcome Measure Information:
Title
Complete remission rate, duration of complete remission, toxicities
Time Frame
06/2008
Secondary Outcome Measure Information:
Title
progression-free survival, overall survival
Time Frame
06/2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yae-Eun Jang, nurse
Phone
80-2-3010-7290
Email
redpin75@paran.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hawk Kim, professor
Organizational Affiliation
Ulsan Universtity Hospital, ROK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yae-Eun, Jang
Phone
82-2-3010-7290
Email
redpin75@paran.com
First Name & Middle Initial & Last Name & Degree
Hawk Kim, professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
25891993
Citation
Kim H, Lee JH, Joo YD, Bae SH, Lee JH, Kim DY, Lee WS, Ryoo HM, Jo JC, Choi Y, Lee KH; CoOperative Study Group A for Hematology (COSAH). A prospective, multicenter phase II study of continuous infusion of FLAG for patients older than 60 yr with resistant acute myeloid leukemia: a comparison with intensive younger patients' trial. Eur J Haematol. 2016 Feb;96(2):188-97. doi: 10.1111/ejh.12568. Epub 2015 May 6.
Results Reference
derived
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FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML
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