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A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a

NCT01724021 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 743

Last updated 2018-01-23

Study results available
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Summary

This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.

Conditions

  • Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma

Interventions

DRUG

Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)

Standard chemotherapy

DRUG

Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)

Standard chemotherapy

DRUG

Bendamustine

Standard chemotherapy

DRUG

Rituximab

1400 mg subcutaneously (SC), Day 1 Cycles 2-4

DRUG

Rituximab

375 mg/m2 IV, Day 1 Cycles 1-4

DRUG

Rituximab

375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8

DRUG

Rituximab

1400 mg SC, Day 1 Cycles 5-8

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
2012-12-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Denmark
  • Dominican Republic
  • Egypt
  • El Salvador
  • Germany
  • Guatemala
  • Hong Kong
  • Hungary
  • Indonesia
  • Italy
  • Malaysia
  • Netherlands
  • New Zealand
  • Panama
  • Peru
  • Philippines
  • Portugal
  • Romania
  • South Korea
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
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 NCT01724021 on ClinicalTrials.gov