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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
Cooperative Study Group A for Hematology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 18, 2007
Last Updated
November 18, 2007
Sponsor
Cooperative Study Group A for Hematology
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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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