ActivePhase 3ACTRN12610000445077

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.


Sponsor

Cephalon Inc

Enrollment

436 participants

Start Date

Jun 1, 2009

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy combinations for treating slow-growing types of non-Hodgkin's lymphoma or mantle cell lymphoma that have not been previously treated. It is for adults aged 18 and older with confirmed CD20-positive B-cell lymphoma who need treatment and are in generally adequate health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

United States of America

Canada

Brazil

Argentina

Christchurch - Christchurch Hospital, New Zealand

Wellington - Wellington Hospital, New Zealand

Palmerston North - Palmerston North Hospital, New Zealand

Auckland - Auckland City Hospital, New Zealand

Auckland - North Shore Hospital, New Zealand

Auckland - Middlemore Hospital, New Zealand

Peru

Mexico

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