At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 360 enrolled
Drug / intervention
rituximab [MabThera/Rituxan] +1 moredrug
Likely dose
rituximab [MabThera/Rituxan] 375mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating rituximab [MabThera/Rituxan] and Standard chemotherapy for Non-Hodgkin's Lymphoma. Completed, enrolled 360 participants across 33 sites.
Detailed Summary
This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 1998
First PostedDec 2005
Primary CompletionApr 2009
TodayJul 2026
First PostedDec 23, 2005
Enrollment StartSep 1, 1998
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 20.5 years ago
Interventions
rituximab [MabThera/Rituxan]drug
375mg/m2 iv monthly for 8 cycles
Standard chemotherapydrug
As prescribed