Rituximab in Primary Central Nervous system Lymphoma.A randomized HOVON / ALLG intergroup study.
Recruiting
- Conditions
- Primary Central Nervous System Lymphoma (PCNSL)
- Registration Number
- NL-OMON20855
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedP.O. box 52013008 AE RotterdamTel: +31 10 7041560Fax: +31 10 7041028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Patients with a histologically confirmed diagnosis of CD20 positive DLBCL based upon a representative histology specimen of brain biopsy according to the WHO classification;
OR
Exclusion Criteria
1. Evidence of systemic lymphoma;
2. History of intolerance of exogenous protein administration;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of the addition of rituximab in a standard chemotherapy regime on EFS in newly diagnosed PCNSL.<br><br /><br /><br>Event-free survival at 1, 3 and 5 years of all patients defined as failure (relapse, no CR or CRu) or death from any cause.
- Secondary Outcome Measures
Name Time Method To evaluate the effect of the addition of rituximab to a standard chemotherapy regimen with respect to:<br /><br>1. Response rates after (R-) MBVP, after HD-Ara-C and after completion of radiotherapy;<br /><br>2. Toxicity (until 30 days after off protocol treatment);<br /><br>3. Overall survival;<br /><br>4. Cognitive function and quality of life after treatment.