A Study of MabThera/Rituxan (Rituximab) in Patients With 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

NCT01388959

M39012

Details and patient eligibility

About

This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, 18-75 years of age
• Diagnosis of follicular non-Hodgkin's lymphoma (FNHL)
• Previously treated with chemotherapy with autologous haemotopoietic stem cell transplantation (bone marrow or peripheral blood cells)

Exclusion criteria

• Active viral hepatitis
• Eastern Cooperative Oncology Group (ECOG) performance status >2
• Patients not willing to sign informed consent form

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Single arm

Experimental group

Treatment:

Drug: rituximab [MabThera/Rituxan]