Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatments chemotherapy, rituximab [mabthera/rituxan]
Phase phase 4
Target CD20
Sponsor Hoffmann-La Roche
Start date December 2011
End date March 2019
Trial size 694 participants
Trial identifier NCT01461928, 2010-023407-95, MO25455

Summary

This multicenter, randomized, parallel-group study will evaluate the efficacy and safety of subcutaneously (sc) administered MabThera/Rituxan (rituximab) in comparison with observation only as maintenance therapy in patients with relapsed or refractory indolent non-Hodgkin's lymphoma. All patients will receive 6-8 cycles of induction therapy with MabThera/Rituxan (375 mg/m2 iv in Cycle 1, then 1400 mg sc every 3-4 weeks) plus standard chemotherapy, followed by 24 months of maintenance therapy with MabThera/Rituxan (1400 mg sc every 8 weeks). Patients completing therapy and showing partial or complete response will be randomized to receive either MabThera/Rituxan (1400 mg sc every 8 weeks) or observation with no treatment during maintenance phase II 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
chemotherapy
Induction phase: standard combination chemotherapy, 6 to 8 cycles
rituximab [mabthera/rituxan]
Maintenance II: 1400 mg sc every 8 weeks until disease progression or end of study, whichever occurs first
rituximab [mabthera/rituxan]
Induction therapy: 375 mg/m2 iv in Cycle 1, followed by 1400 mg sc every 3-4 weeks, 7 cycles
rituximab [mabthera/rituxan]
Maintenance I: 1400 mg sc every 8 weeks for 24 months
(Other)
chemotherapy
Induction phase: standard combination chemotherapy, 6 to 8 cycles
rituximab [mabthera/rituxan]
Induction therapy: 375 mg/m2 iv in Cycle 1, followed by 1400 mg sc every 3-4 weeks, 7 cycles
rituximab [mabthera/rituxan]
Maintenance I: 1400 mg sc every 8 weeks for 24 months

Primary Outcomes

Measure
Progression-free survival (Maintenance II phase): from randomization to disease progression or death; tumour assessments according to the 1999 International Working Group response (Cheson) criteria for lymphoma
time frame: approximately 24 months

Secondary Outcomes

Measure
Safety: Incidence of adverse events
time frame: approximately 6 years
Event-free survival (time to treatment failure): from day of first rituximab induction dose to day of any treatment failure, including disease progression, or discontinuation of treatment for any reason
time frame: approximately 6 years
Time to next lymphoma treatment: from day of first rituximab induction dose to any new lymphoma treatment
time frame: approximately 6 years
Overall survival (from 1st induction dose/from time to randomization)
time frame: approximately 6 years
Overall Response Rate
time frame: approximately 6 years
Partial Response to Complete Response conversion rate (at end of Maintenance I phase)
time frame: approximately 6 years
Progression-free survival: from day of first induction dose until disease progression or death by any cause
time frame: approximately 6 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Histologically confirmed CD20+ indolent non-Hodgkin's lymphoma according to WHO classification system - Patients must have received and must have relapsed or been refractory to one or more lines of adequate therapy prior to enrolment, including at least one line consisting of immunotherapy and/or chemotherapy and/or radiotherapy - Eastern Cooperative Oncology Group (ECOG) performance status

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.