At a glance
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A Single Arm, Multicentre, Phase IIIB Study to Evaluate Safety, Efficacy and Pharmacokinetic (PK) of Subcutaneous (SC) Rituximab Administered During Induction Phase or Maintenance in Previously Untreated Patients With CD20+ Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)
In Brief
A Phase 3 clinical trial evaluating Rituximab, Cyclophosphamide, and 4 other interventions for Lymphoma. Completed, enrolled 159 participants across 39 sites.
Detailed 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.
Study Details
Timeline
Interventions
Rituximab will be administered at a dose of 1400 mg SC once a month for at least 4 doses during the Induction period, and at a dose of 1400 mg SC once every two months for at least 6 doses during the Maintenance period.
Cyclophosphamide will be administered as per standard local practice as a part of standard chemotherapy regimen.
Vincristine will be administered as per standard local practice as a part of standard chemotherapy regimen.
Doxorubicin will be administered as per standard local practice as a part of standard chemotherapy regimen.
Prednisone will be administered as per standard local practice as a part of standard chemotherapy regimen.
Bendamustine will be administered as per standard local practice as a part of standard chemotherapy regimen.