Back to resultsA Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
Primary Purpose
Acute Lymphoblastic Leukemia
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CODOX-M
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Patients with relapsed/resistant acute lymphoblastic leukemia
- Patients must be between 15 and 65 years of age.
- Estimated life expectancy of more than 3 months
- ECOG performance status of 2 or lower, Karnofsky scale > 60 (see appendix I)
- Adequate cardiac function (EF>45%) on echocardiogram or MUGA scan
- Adequate kidney function (estimated Ccr >50 ml/min)
Exclusion Criteria:
- Patients with CNS involvement of leukemic blasts will not be excluded.
- Patients with extramedullary relapse(s) only will be excluded.
Sites / Locations
- Asan Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Duration of complete remission, disease-free survival, overall survival, toxicities
Secondary Outcome Measures
Full Information
NCT ID
NCT00774332
First Posted
October 15, 2008
Last Updated
October 15, 2008
Sponsor
Cooperative Study Group A for Hematology
1. Study Identification
Unique Protocol Identification Number
NCT00774332
Brief Title
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
Official Title
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
December 2009 (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
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
Detailed Description
The feasibility will be evaluated in terms of complete remission rate, duration of complete remission, disease-free survival, overall survival, and toxicities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
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
Intervention Type
Drug
Intervention Name(s)
CODOX-M
Intervention Description
Cytoxan,Mesna,Adriamycin,Vincristine,Methotrexate,Leucovorin,Cytarabine
Primary Outcome Measure Information:
Title
Duration of complete remission, disease-free survival, overall survival, toxicities
Time Frame
2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with relapsed/resistant acute lymphoblastic leukemia
Patients must be between 15 and 65 years of age.
Estimated life expectancy of more than 3 months
ECOG performance status of 2 or lower, Karnofsky scale > 60 (see appendix I)
Adequate cardiac function (EF>45%) on echocardiogram or MUGA scan
Adequate kidney function (estimated Ccr >50 ml/min)
Exclusion Criteria:
Patients with CNS involvement of leukemic blasts will not be excluded.
Patients with extramedullary relapse(s) only will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-Hee Lee, doctor
Phone
82-2-3010-5794
Email
jhleecr@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Hee Lee, Doctor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung-Hee Lee, Doctor
Phone
82-2-3010-5794
Email
jhleecr@amc.seoul.kr
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
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