Conditions: Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 159
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 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, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); or bendamustine as per standard local practice.

Interventions: intervention 1: Rituximab intervention 2: Cyclophosphamide intervention 3: Vincristine intervention 4: Doxorubicin intervention 5: Prednisone intervention 6: Bendamustine
Intervention descriptions: intervention 1: 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. intervention 2: Cyclophosphamide will be administered as per standard local practice as a part of standard chemotherapy regimen. intervention 3: Vincristine will be administered as per standard local practice as a part of standard chemotherapy regimen. intervention 4: Doxorubicin will be administered as per standard local practice as a part of standard chemotherapy regimen. intervention 5: Prednisone will be administered as per standard local practice as a part of standard chemotherapy regimen. intervention 6: Bendamustine will be administered as per standard local practice as a part of standard chemotherapy regimen.

Protocol document:
Prot_001.pdf: 
 
Official Title: 
 
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) 
NCT Number: 
NCT01889069 
Document Date: 
Protocol Version 4: 08-Sep-2016 
 
 
 






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





SAP_000.pdf: 
 
Official Title: 
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) 
NCT Number: 
NCT01889069 
Document Date: 
SAP Version 1: 31-Jan-2017