A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL.

Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Collaborator: Hoffmann-La Roche
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• 4 to 8 cycles R-CHOP/like, total of 8x Rituximab

• CR, CRu

• ECOG/ 0.1 or 2

• Known IPI at time of diagnosis

• Age > 18 years

• Negative pregnancy test

• Men must agree not to father a child during the therapy

Exclusion Criteria:

• Transformed lymphoma

• Secondary malignancy

• Evidence of CNS - involvement

• Significant cardiac disease

• Creatinine > 2.0 mg/dl

• HIV, Hepatitis positive