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A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab

NCT01461928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2019-08-06

Study results available
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Summary

This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously \[IV\] in Cycle 1, then 1400 mg subcutaneous \[SC\] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Chemotherapy (Induction Period)

Participants will receive standard combination chemotherapy every 3-4 weeks for 6 to 8 months. The chemotherapy regimen will be selected at Investigator's discretion, for individual participant. Study protocol does not enforce any particular chemotherapy regimen.

DRUG

Rituximab

Participants will receive rituximab according to the regimen specified in individual arm.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-20
Primary Completion
2018-06-02
Completion
2018-06-02
FDA Drug
Yes

Countries

  • Albania
  • Argentina
  • Austria
  • Brazil
  • Bulgaria
  • Colombia
  • Ecuador
  • Egypt
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Norway
  • Romania
  • Russia
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

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 NCT01461928 on ClinicalTrials.gov