N/A N=41

A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma

Lymphoma, Follicular

Bottom Line

View on ClinicalTrials.gov: NCT02472756 ↗

Enrolled (actual)

Serious AEs

19.5%

Results posted

Aug 2016

Primary outcome: Primary: Percentage of Participants With Objective Response — 92.3 percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Chemotherapy (Drug); Rituximab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Objective Response	92.3	—
PRIMARY Percentage of Participants With Complete Remission (CR)	56.4	—
PRIMARY Percentage of Participants Who Were Alive at Year 2	85	—

Summary

This is a Phase 4, open, prospective, non-interventional, multicenter trial for previously treated adult participants with relapsed/refractory follicular lymphoma (FL). Eligible participants with FL will receive 6-8 infusions of induction standard regimen of rituximab plus chemotherapy. Participants with complete or partial remission at end of induction will be assigned to maintenance therapy with rituximab once every 3 months for a maximum of 2 years or until relapse. The choice of the treatment regimen will be established on a per center basis, according to the standard in use in the country and in the center, and each center will use the same regimen through the study. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice.

Eligibility Criteria

Inclusion Criteria

Participants diagnosed with FL and had already received one or more treatments

Exclusion Criteria

Participants who are not eligible for rituximab treatment according to summary of product characteristics (SmPC)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02472756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.