Back to resultsTreatment of Disseminated High Grade Lymphoma
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Doxorubicin
Doxorubicin pegylated
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring diffuse larg cells lymphoma, chemotherapy, toxicity, diffuse high grade lymphoma
Eligibility Criteria
Inclusion Criteria:
- high grade lymphoma
- disseminated
- > 60 years old and < 75
- informed consent signed
- cardiac state compatible with antracyclin
- ECOG </= 2
Exclusion Criteria:
- patients > 75 years old
- Cardiac insufficiency
Sites / Locations
- Clinique Victor Hugo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Doxorubicine
Doxorubicine pegylated
Arm Description
CHOP 8 courses every 21 days
CLOP 8 courses every 21 days
Outcomes
Primary Outcome Measures
hematologic toxicity
Secondary Outcome Measures
response rate
EFS and OS
Cardiac toxicity
Full Information
NCT ID
NCT00536393
First Posted
September 26, 2007
Last Updated
October 31, 2007
Sponsor
French Innovative Leukemia Organisation
1. Study Identification
Unique Protocol Identification Number
NCT00536393
Brief Title
Treatment of Disseminated High Grade Lymphoma
Official Title
Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
French Innovative Leukemia Organisation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Interest of the use of pegylated liposomal doxorubicin (caélyx)
Detailed Description
R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
diffuse larg cells lymphoma, chemotherapy, toxicity, diffuse high grade lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doxorubicine
Arm Type
Active Comparator
Arm Description
CHOP 8 courses every 21 days
Arm Title
Doxorubicine pegylated
Arm Type
Experimental
Arm Description
CLOP 8 courses every 21 days
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Type
Drug
Intervention Name(s)
Doxorubicin pegylated
Primary Outcome Measure Information:
Title
hematologic toxicity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
response rate
Time Frame
6 months
Title
EFS and OS
Time Frame
6 months
Title
Cardiac toxicity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
high grade lymphoma
disseminated
> 60 years old and < 75
informed consent signed
cardiac state compatible with antracyclin
ECOG </= 2
Exclusion Criteria:
patients > 75 years old
Cardiac insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume CARTRON, Dr
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72015
Country
France
12. IPD Sharing Statement
Learn more about this trial
Treatment of Disseminated High Grade Lymphoma
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