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

October 29, 2020 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

688

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, 45122
        • Universitätsklinikum Essen; Klinik für Hämatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CD-20 positive, diffuse large cell B-cell non-Hodgkin lymphoma (DLBCL) and CD-20 positive follicular non-Hodgkin lymphoma (NHL)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Follicular NHL Cohort
DLBCL Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients in both indications (DLBCL and follicular NHL) who have reached a complete remission (CR), including unconfirmed complete remission (CRu)
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Total response rate
Time Frame: Up to 2.5 years
Up to 2.5 years
Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy
Time Frame: 2 years
2 years
Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure)
Time Frame: Up to 2.5 years
Up to 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 8, 2014

Primary Completion (ACTUAL)

July 22, 2019

Study Completion (ACTUAL)

July 22, 2019

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (ESTIMATE)

September 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28886

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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