A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01153971

ML18324

Details and patient eligibility

About

This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients 18-65 years of age;
• previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
• active disease;
• >=3 involved sites.

Exclusion criteria

• typical chronic lymphocytic leukemia;
• other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
• systemic corticosteroid use for >1 month;
• significant cardiovascular disease;
• central nervous system involvement;
• hepatitis B or C virus infection, or HIV infection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

1

Experimental group

Treatment:

Drug: rituximab