Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma
Primary Purpose
Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GemDOx
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Patients who have refractory to first-line CHOP-like regimen
- Patients who have first relapse after
- first-line CHOP-like regimen
- upfront autologous or allogeneic hematopoietic stem cell transplantation
- Age 15 years or more
- ECOG performance status ≤ 2
- Adequate bone marrow function
- Adequate kidney,liver,cardiac
Exclusion Criteria:
- Patients who have received GEM or OX
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
objective response rate
Secondary Outcome Measures
toxicities, progression-free survival, overall survival, ASCC efficacy, rate for proceeding to ASCT
Full Information
NCT ID
NCT00561301
First Posted
November 18, 2007
Last Updated
November 18, 2007
Sponsor
Cooperative Study Group A for Hematology
1. Study Identification
Unique Protocol Identification Number
NCT00561301
Brief Title
Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma
Official Title
Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 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
- To evaluate the feasibility of combination chemotherapies comprising of gemcitabine-dexamethasone-oxaliplatin for patients with refractory or relapsed malignant non-Hodgkin lymphoma (NHL)
Detailed Description
- The feasibility will be evaluated in terms of objective response rate, efficacy of stem cell collection, 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
Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
GemDOx
Intervention Description
gemcitabine oxliplatin
Primary Outcome Measure Information:
Title
objective response rate
Time Frame
10/2009
Secondary Outcome Measure Information:
Title
toxicities, progression-free survival, overall survival, ASCC efficacy, rate for proceeding to ASCT
Time Frame
10/2009
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 who have refractory to first-line CHOP-like regimen
Patients who have first relapse after
first-line CHOP-like regimen
upfront autologous or allogeneic hematopoietic stem cell transplantation
Age 15 years or more
ECOG performance status ≤ 2
Adequate bone marrow function
Adequate kidney,liver,cardiac
Exclusion Criteria:
Patients who have received GEM or OX
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yae Eun Jang
Phone
82-2-3010-7290
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
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yae-Eun Jang, nurse
Phone
82-2-3010-7290
Email
redpin75@naver.com
12. IPD Sharing Statement
Learn more about this trial
Biweekly Gemcitabine-Oxaliplatin and Dexamethasone for Relapsed/Refractory Malignant Lymphoma
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