NCT01392716
Completed
Phase 2
An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma
ConditionsNon-Hodgkin's Lymphoma
Interventionsrituximab [MabThera/Rituxan]
Overview
- Phase
- Phase 2
- Intervention
- rituximab [MabThera/Rituxan]
- Conditions
- Non-Hodgkin's Lymphoma
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 48
- Primary Endpoint
- Overall objective complete response rate
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in treatment-naive patients with non-bulky follicular non-Hodgkin's lymphoma. The anticipated time on study treatment is 3 months.
Investigators
Eligibility Criteria
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
Arms & Interventions
Single arm
Intervention: rituximab [MabThera/Rituxan]
Outcomes
Primary Outcomes
Overall objective complete response rate
Time Frame: Day 50
Overall objective partial response rate
Time Frame: Day 50
Secondary Outcomes
- Progression-free survival(7 years)
- Overall survival(7 years)
- Level of biological marker bcl2 in peripheral blood and bone marrow(7 years)
- Duration of response(7 years)
- Safety: Incidence of adverse events(7 years)
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