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
NCT00553943 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2018-08-23
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
- DRUG
-
375 mg/m2 D1
- DRUG
-
50 mg D3
Sponsors & Collaborators
-
Lymphoma Study Association
lead OTHER
Principal Investigators
-
Herve Ghesquieres, MD · LYmphoma Study Association (LYSA)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-07-31
- Primary Completion
- 2012-06-30
- Completion
- 2017-03-31
Countries
- Belgium
- France
Study Locations
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