Trial Information
A Randomized, Open-label Study of the Effect of MabThera Plus Chemotherapy Versus Chemotherapy Alone on Clinical Response in Patients With Indolent Non-Hodgkin's and Mantle Cell Lymphoma
Inclusion Criteria:
- adult patients >=18 years of age;
- advanced, low-grade non-Hodgkin's and mantle cell lymphoma.
Exclusion Criteria:
- possibility of curative radiation therapy;
- secondary NHL;
- participation in another clinical trial eg with cytostatic chemotherapy or cytokines;
- concomitant diseases and/or restricted organ function precluding therapy according to
the study protocol.
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:
Clinical response (complete or partial remission).
Outcome Time Frame:
After 8 months of treatment
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
M39023
NCT ID:
NCT00269113
Start Date:
September 1998
Completion Date:
April 2009
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Mantle-Cell