An Observational Study of Patients With Malignant Lymphomas Treated With MabThera® SC in Everyday Clinical Practice

NCT ID: NCT02240316

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

688 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-08

Study Completion Date

2019-07-22

Brief Summary

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This observational study aims to assess the therapeutic responsiveness of MabThera SC in patients with malignant lymphomas under everyday clinical practice conditions. Patients with previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy with MabThera SC according to the assessment of the physician will be prospectively enrolled for observation. No study specific measures are required; treatment and documentation will be performed according to usual clinical practice.

Detailed Description

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Conditions

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Lymphoma, B-Cell, Lymphoma, Follicular

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Follicular NHL Cohort

No interventions assigned to this group

DLBCL Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women and men aged \>=18 years
* Previously untreated CD-20 positive follicular NHL
* Previously untreated CD-20 positive DLBCL
* Planned therapy with MabThera SC according to the assessment of the physician (before the start and independent from this study)
* Suitability for the therapy with MabThera SC

Exclusion Criteria

All contraindications, interactions and incompatibilities for therapy with MabThera SC
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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Universitätsklinikum Essen; Klinik für Hämatologie

Essen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML28886

Identifier Type: -

Identifier Source: org_study_id