NCT00553943

Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis

Prospective Multicentre Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® by Intrathecal Injection in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy: * before cerebral radiotherapy for PCL * after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement Toxicity of the protocol Overall survival Survival without relapse Long-term incidence of neurocognitive toxicity

Conditions

• Lymphoma, Non-Hodgkin
• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m2 D1
DRUG	Cytarabine	50 mg D3

Timeline

• Start date: 2007-07-01
• Primary completion: 2012-06-01
• Completion: 2017-03-01
• First posted: 2007-11-06
• Last updated: 2018-08-23

Locations

46 sites across 2 countries: Belgium, France