An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL).
An open-label, randomized, parallel-group study to compare the complete response (CR) rate of Bendamustine and Rituximab (BR) with that of standard treatment regimens of either Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the first-line treatment of patients with advanced indolent non-Hodgkin's lymphoma or mantle cell lymphoma.
Cephalon Inc
436 participants
Jun 1, 2009
Interventional
Conditions
Summary
This study looks at the effectiveness and safety of the chemotherapy drug Bendamustine in treating advanced slow-growing non-Hodgkin's lymphoma or mantle cell lymphoma. Who is it for? You may be able to join this study if you have advanced indolent non-Hodgkin's lymphoma or mantle cell lymphoma. Trial details Participants will be randomly divided into two groups. One group will receive a combination of the drugs Bendamustine and Rituximab (BR). The other will receive standard treatment with either Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP). The study aims to compare the efficacy and safety of the combination of Bendamustine and Rituximab (BR) to the current standard treatments.
Eligibility
Plain Language Summary
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Interventions
Name of intervention being studied: Bendamustine Hydrochloride (administered in combination with Rituximab) Patients will be randomly assigned to either investigational treatment (BR) or standard treatment (R-CVP or R-CHOP). Six cycles of treatment are planned, with a maximum of eight treatment cycles permitted as the discretion of the investigator and after discussion with the sponsor or sponsor's designee. If randomised to the investigational treatment arm, patients will receive Bendamustine Hydrochloride at 90mg per metre squared (body surface area) intravenously on days 1 and 2 of each 28-day cycle. Additionally, patients will receive Rituximab at 375mg per metre squared intravenously on day 1 of every cycle of treatment. The Bendamustine and Rituximab are infused separately: * Bendamustine: approximately 30 minute infusion * Rituximab: Infusion duration will vary depending on the size (height and weight) of the patient: - Cycle 1 - approximately 3-5 hours - Cycle 2 onwards - approximately 2-4 hours (if Cycle 1 was well tolerated)
Locations(12)
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ACTRN12610000445077