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An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Terminated
CT.gov ID
NCT01609036
Collaborator
(none)
3
Enrollment
4
Locations
1
Duration (Months)
0.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) in previously untreated patients with follicular lymphoma. Data will be collected for 3 years

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Phase IV Non Interventional Study in Patients With Advanced Follicular Lymphoma (III-IV) Evaluating the Safety of Maintenance Therapy With Rituximab After 8 Cycles of Rituximab in Combination With Chemotherapy as Induction Therapy in Previously Untreated Patients in Greece.
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Nov 1, 2012
    Actual Study Completion Date :
    Nov 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort

    Outcome Measures

    Primary Outcome Measures

    1. Safety: Incidence of adverse events [3 years]

    Secondary Outcome Measures

    1. Progression-free survival [3 years]

    2. Event-free survival [3 years]

    3. Overall survival [3 years]

    Eligibility Criteria

    Criteria

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

    • Adult patients, >/=18 years

    • Patients with previously untreated follicular lymphoma (stage III-IV) according to the approved summary of product characteristics (SPC)

    Exclusion Criteria:
    • Contraindications to MabThera/Rituxan therapy according to the approved SPC

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Athens Greece 106 76
    2 Athens Greece 115 27
    3 Patras Greece 265 00
    4 Thessaloniki Greece 570 10

    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:
    NCT01609036
    Other Study ID Numbers:
    • ML22236
    First Posted:
    May 31, 2012
    Last Update Posted:
    Nov 2, 2016
    Last Verified:
    Nov 1, 2016
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular

    Study Results

    No Results Posted as of Nov 2, 2016