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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT01392716 |
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Date of registration:
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05/07/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of MabThera/Rituxan (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma
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Scientific title:
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An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma |
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Date of first enrolment:
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October 1997 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01392716 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients 18-75 years of age
- Newly diagnosed non-bulky follicular non-Hodgkin's lymphoma
- >/=1 measurable lesion
- No prior treatment (no corticosteroids or radiotherapy)
Exclusion Criteria:
- Transformed follicular lymphoma
- Cerebral or meningeal lymphomaotus localization
- Uncontrolled concurrent infection
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Hodgkin's Lymphoma
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Intervention(s)
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Drug: rituximab [MabThera/Rituxan]
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Primary Outcome(s)
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Overall objective partial response rate
[Time Frame: Day 50]
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Overall objective complete response rate
[Time Frame: Day 50]
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Secondary Outcome(s)
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Duration of response
[Time Frame: 7 years]
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Safety: Incidence of adverse events
[Time Frame: 7 years]
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Overall survival
[Time Frame: 7 years]
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Level of biological marker bcl2 in peripheral blood and bone marrow
[Time Frame: 7 years]
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Progression-free survival
[Time Frame: 7 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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