A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma

Last updated: November 5, 2015
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Lymphoma

Follicular Lymphoma

Treatment

N/A

Clinical Study ID

NCT02569996
ML18167
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult participants greater than (>) 18 years of age

  • Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsywithin 4 months of induction treatment

  • No previous anti-lymphoma treatment before induction chemotherapy (first-line-treatedparticipants only are eligible)

  • Verified complete or partial remission after first-line induction therapy includingrituximab

Exclusion

Exclusion Criteria:

  • Grade 3b follicular lymphoma

  • Transformation to high-grade lymphoma (except to Grade 3a) of previously existingfollicular lymphoma

  • Presence of central nervous system lymphoma

  • Acquired immunodeficiency syndrome-related lymphoma

  • Other primary malignancy (other than squamous cell cancer of the skin or in situcancer of the cervix) for which the participant has not been disease-free for greaterthan or equal to (>=) 5 years

Study Design

Total Participants: 124
Study Start date:
July 01, 2005
Estimated Completion Date:
August 31, 2013

Connect with a study center

  • Budapest, 1085
    Hungary

    Site Not Available

  • Debrecen, 4032
    Hungary

    Site Not Available

  • Gyor, 9024
    Hungary

    Site Not Available

  • Gyula, 5700
    Hungary

    Site Not Available

  • Kaposvar, 7400
    Hungary

    Site Not Available

  • Miskolc, 3529
    Hungary

    Site Not Available

  • Nyíregyháza, 4400
    Hungary

    Site Not Available

  • Pecs, 7624
    Hungary

    Site Not Available

  • Szeged, 6720
    Hungary

    Site Not Available

  • Szekszard, 7100
    Hungary

    Site Not Available

  • Szolnok, 5004
    Hungary

    Site Not Available

  • Szombathely, 9700
    Hungary

    Site Not Available

  • Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Tatabánya, 2800
    Hungary

    Site Not Available

  • Veszprem, 8200
    Hungary

    Site Not Available

  • Zalaegerszeg, 8900
    Hungary

    Site Not Available

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