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

NCT01998893

M39004

Details and patient eligibility

About

This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is <3 months.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >= 18 years of age;
• centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
• relapse after chemotherapy (with or without interferon maintenance therapy).

Exclusion criteria

• primary refractory lymphomas;
• more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
• clinically significant cardiac disease.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

38 participants in 1 patient group

MabThera/Rituxan

Experimental group

Treatment:

Drug: rituximab [MabThera/Rituxan]