An Open-label, Multi-center, Randomized Study to Evaluate the Efficacy on Tumor Response of GA101 (RO5072759) Monotherapy Versus Rituximab Monotherapy in Patients With Relapsed CD20+ Indolent Non-Hodgkin's Lymphoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma
Both
Non-Hodgkin's Lymphoma
Trial Information
An Open-label, Multi-center, Randomized Study to Evaluate the Efficacy on Tumor Response of GA101 (RO5072759) Monotherapy Versus Rituximab Monotherapy in Patients With Relapsed CD20+ Indolent Non-Hodgkin's Lymphoma
Inclusion Criteria:
- adult patients, >=18 years of age
- relapsed CD20+ indolent B-cell non-Hodgkin's lymphoma
- documented history of response of >/= 6 months duration from last
rituximab-containing regimen
- clinical indication for treatment as determined by the investigator
- ECOG performance status 0-2
Exclusion Criteria:
- prior use of any investigational monoclonal antibody within 6 months of study start
- prior use of any anti-cancer vaccine
- prior use of rituximab within 8 weeks of study entry
- radioimmunotherapy within 3 months prior to study entry
- CNS lymphoma or evidence of transformation to high-grade or diffuse large B-cell
lymphoma
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase 2: Overall response rate
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Canada: Health Canada
Study ID:
BO21003
NCT ID:
NCT00576758
Start Date:
January 2008
Completion Date:
March 2013
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Albany, Georgia 31701 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Hackensack, New Jersey 07601 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Charlotte, North Carolina |
