An observational study in Lymphoma, B-Cell, Lymphoma, Follicular, sponsored by Hoffmann-La Roche. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-30.
Sponsored by Hoffmann-La Roche · Observational
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 688 is above the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
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CD-20 positive, diffuse large cell B-cell non-Hodgkin lymphoma (DLBCL) and CD-20 positive follicular non-Hodgkin lymphoma (NHL)
Exclusion Criteria:
All contraindications, interactions and incompatibilities for therapy with MabThera SC
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
Total response rate
Time frame: Up to 2.5 years
Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy
Time frame: 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
Plan to share: Yes — 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).
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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