A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma

Roche

Status and phase: Completed; Phase 3

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Standard chemotherapy; Drug: rituximab [MabThera/Rituxan]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00269113

M39023

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 360 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• advanced, low-grade non-Hodgkin's and mantle cell lymphoma.

Exclusion criteria

• possibility of curative radiation therapy;
• secondary NHL;
• participation in another clinical trial eg with cytostatic chemotherapy or cytokines;
• concomitant diseases and/or restricted organ function precluding therapy according to the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

360 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: rituximab [MabThera/Rituxan]

Drug: Standard chemotherapy

2

Active Comparator group

Treatment:

Drug: Standard chemotherapy