A Study of MabThera/Rituxan (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: rituximab [MabThera/Rituxan]

• Registration Number: NCT01392716
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-10
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

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Exclusion Criteria

• Transformed follicular lymphoma
• Cerebral or meningeal lymphomaotus localization
• Uncontrolled concurrent infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	rituximab [MabThera/Rituxan]	-

Primary Outcome Measures

Name	Time	Method
Overall objective complete response rate	Day 50
Overall objective partial response rate	Day 50

Secondary Outcome Measures

Name	Time	Method
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