Phase 3
N=360
A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00269113 ↗Enrolled (actual)
360
Serious AEs
10.6%
Results posted
Jul 2015
Primary outcome: Primary: Percentage of Participants Achieving CR or PR at the End of Therapy — 75.0; 92.4 percentage of participants — p=0.0009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rituximab [MabThera/Rituxan] (Drug); Standard chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving CR or PR at the End of Therapy |
75.0; 92.4 | 0.0009 sig |
| SECONDARY Progression-Free Survival (PFS) - Percentage of Participants Event Free at 24 Months |
57.6; 86.7 | <0.0001 sig |
| SECONDARY Overall Survival (OS) - Percentage of Participants Alive at 24 Months |
78.8; 93.7 | 0.0127 sig |
| SECONDARY Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months |
50.9; 83.6 | <0.0001 sig |
| SECONDARY Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months |
69.6; 86.5 | 0.0186 sig |
| SECONDARY Response Duration - Percentage of Participants Event Free at 24 Months |
60.3; 87.7 | 0.0002 sig |
| SECONDARY Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months |
54.6; 72.0 | 0.0017 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00269113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.