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

Sponsor
Hoffmann-La Roche
Study ID
NCT02472756
Status
Completed

Conditions

  • Lymphoma, Follicular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy — DRUG
    The choice of the chemotherapy regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.
  • Rituximab — DRUG
    The choice of the rituximab regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.

Study Details

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.

Key Dates

Start date
Sep 19, 2008
Status verified
Jun 2017
Primary completion
May 30, 2014
Completion
May 30, 2014

Study Design

Enrollment
41 participants (actual)

Arms

  • Arm: Follicular Lymphoma Participants
    Previously treated adult participants with relapsed/refractory FL will receive rituximab in combination with chemotherapy regimen. All treatments prescribed during the observation period will be at the treating physician's discretion. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.

Primary Outcome Measure

Percentage of Participants With Objective Response [ Time Frame: Baseline until disease progression or death, whichever occurred first (up to approximately 6 months) ]

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