A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma
NCT ID: NCT02569996
Last Updated: 2015-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
124 participants
INTERVENTIONAL
2005-07-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab
Participants will receive rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.
Rituximab
Rituximab will be administered at 375 mg/m\^2 every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.
Interventions
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Rituximab
Rituximab will be administered at 375 mg/m\^2 every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment
* No previous anti-lymphoma treatment before induction chemotherapy (first-line-treated participants only are eligible)
* Verified complete or partial remission after first-line induction therapy including rituximab
Exclusion Criteria
* Transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular 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 situ cancer of the cervix) for which the participant has not been disease-free for greater than or equal to (\>=) 5 years
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Gyula, , Hungary
Kaposvár, , Hungary
Miskolc, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Székesfehérvár, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Tatabánya, , Hungary
Veszprém, , Hungary
Zalaegerszeg, , Hungary
Countries
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Other Identifiers
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ML18167
Identifier Type: -
Identifier Source: org_study_id