drugset / Trial / NCT01889069
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)
NaSingle-groupOpen-labelTreatment
Summary
This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy, participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period.
Timeline
- Start
- 2013-07-31
- Primary completion
- 2019-05-28
- Completion
- 2019-05-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 1400 mg | Subcutaneous |
| Background | Bendamustine | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Vincristine | Small molecule | — | — |