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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02240316
Collaborator
(none)
688
Enrollment
1
Location
60.5
Actual Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    688 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Jul 8, 2014
    Actual Primary Completion Date :
    Jul 22, 2019
    Actual Study Completion Date :
    Jul 22, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Follicular NHL Cohort
    DLBCL Cohort

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients in both indications (DLBCL and follicular NHL) who have reached a complete remission (CR), including unconfirmed complete remission (CRu) [Up to 2 years]

    Secondary Outcome Measures

    1. Total response rate [Up to 2.5 years]

    2. Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy [2 years]

    3. Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure) [Up to 2.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsklinikum Essen; Klinik für Hämatologie Essen Germany 45122

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02240316
    Other Study ID Numbers:
    • ML28886
    First Posted:
    Sep 15, 2014
    Last Update Posted:
    Oct 30, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Follicular

    Study Results

    No Results Posted as of Oct 30, 2020