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

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: rituximab [MabThera/Rituxan]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01392716

M39006

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Single arm

Experimental group

Treatment:

Drug: rituximab [MabThera/Rituxan]