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A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma

NCT01649856 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2017-10-11

Study results available
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Summary

This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Interventions

DRUG

CHOP

CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles

DRUG

rituximab [MabThera/Rituxan]

The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles

DRUG

rituximab [MabThera/Rituxan]

375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-24
Primary Completion
2014-10-21
Completion
2016-09-16

Countries

  • Algeria
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Finland
  • France
  • Greece
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Peru
  • Poland
  • Portugal
  • Russia
  • Saudi Arabia
  • Serbia
  • South Africa
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom
  • Venezuela

Study Locations

More Related Trials

Entities

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 NCT01649856 on ClinicalTrials.gov