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

NCT ID: NCT02472756

Last Updated: 2017-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-19

Study Completion Date

2014-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, Follicular

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Chemotherapy

Intervention Type 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

Intervention Type 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.

Interventions

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Chemotherapy

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.

Intervention Type DRUG

Rituximab

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.

Intervention Type DRUG

Other Intervention Names

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MabThera

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Institute of Hematology

Belgrade, , Serbia

Site Status

Clinical Center Bezanijska Kosa

Belgrade, , Serbia

Site Status

Institute For Oncology Sremska Kamenica; Internal Medicine Department

Kamenitz, , Serbia

Site Status

Clinical Center Kragujevac

Kragujevac, , Serbia

Site Status

Clinic of Haematology Cc Nis

Niš, , Serbia

Site Status

Clinical Center Vojvodine; Clinic for Hematology

Novi Sad, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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ML21872

Identifier Type: -

Identifier Source: org_study_id

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