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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)

NCT01889069 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2020-08-13

Study results available
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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.

Conditions

Interventions

DRUG

Rituximab

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.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered as per standard local practice as a part of standard chemotherapy regimen.

DRUG

Vincristine

Vincristine will be administered as per standard local practice as a part of standard chemotherapy regimen.

DRUG

Doxorubicin

Doxorubicin will be administered as per standard local practice as a part of standard chemotherapy regimen.

DRUG

Prednisone

Prednisone will be administered as per standard local practice as a part of standard chemotherapy regimen.

DRUG

Bendamustine

Bendamustine will be administered as per standard local practice as a part of standard chemotherapy regimen.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2019-05-28
Completion
2019-05-28

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01889069 on ClinicalTrials.gov