NCT00400478

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 683 (actual)
• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)
• Follicular NHL Grade 3b

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)

Timeline

• Start date: 2006-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2006-11-17
• Last updated: 2016-05-26

Locations

131 sites across 26 countries: Australia, Austria, Bosnia and Herzegovina, Brazil, Bulgaria, China, Croatia, Czechia, Estonia, Hong Kong, Israel, Latvia, Malaysia, Mexico, North Macedonia, Peru, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Thailand, Turkey (Türkiye)