Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants

NCT ID: NCT02536664

Last Updated: 2023-04-18

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

505 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-06-30

Brief Summary

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It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.

Detailed Description

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Conditions

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Follicular Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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First-line Stratum

Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition.

Rituximab

Intervention Type DRUG

Relapsed/Refractory Stratum

Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition.

Rituximab

Intervention Type DRUG

Interventions

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Rituximab

Intervention Type DRUG

Other Intervention Names

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MabThera®

Eligibility Criteria

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Inclusion Criteria

* Age over 18 years
* Previously untreated, relapsed or refractory CD 20-positive FL
* Responding to rituximab containing induction therapy (complete response \[CR\] or partial response \[PR\])
* To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
* No ineligibility for rituximab

Exclusion Criteria

Not Applicable (NA)
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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Essen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML22283

Identifier Type: -

Identifier Source: org_study_id

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