Primary Central Nervous System Lymphoma (PCNSL)
Conditions
Interventions
In the experimental arm B intravenously administered rituximab will be added to MBVP chemotherapy. Arm A is the standard arm.
The objective of the current study is to investigate whether the addition
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
P.O. box 5201
3008 AE Rotterdam
Tel: +31 10 7041560
Fax: +31 10 7041028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
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 2. Patients with a diagnosis of PCNSL based on MRI evidence of brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma; AND 3. Unequivocal morphological and/or immunophenotypical evidence of CSF CD20 + large cell lymphoma; 4. AND/OR Unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid; OR 5. Patients with unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid AND CSF but without a brain parenchymal lesion; 6. Age 18-70 years inclusive; 7. Performance status with or without administration of steroids WHO/ECOG 0-3; 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence of systemic lymphoma; 2. History of intolerance of exogenous protein administration; 3. Severe cardiac dysfunction (NYHA classification III-IV, appendix G, or LVEF < 45%) Congestive heart failure or symptomatic coronary artery disease or cardiac arythmias not well controlled with medication ; 4. Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value); 5. Significant hepatic dysfunction (bilirubin or transaminase ¡Ý 2.5 x upper normal limit) at Screening; 6. Significant renal dysfunction (serum creatinine ¡Ý150 micromol/l or clearance < 60 ml/min) at Screening; 7. Presence of ¡°third space fluid¡±, such as pleural effusion or ascites; 8. Prior cranial radiotherapy; 9. Active uncontrolled infection; 10. HIV-positivity; 11. (EBV positive) post-transplant lymphoproliferative disorder; 12. Untreated hepatitis B infection (inclusion is possible if adequate antiviral medication e.g. lamivudine or alternative is started and continued for the duration of the trial); 13. Positive pregnancy test in women of reproductive potential; 14. Lactating women; 15. Unable or unwilling to use adequate contraceptive methods (all men, pre-menopausal women) until 12 months after last chemotherapy treatment; 16. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of the addition of rituximab in a standard chemotherapy regime on EFS in newly diagnosed PCNSL. 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
| Measure | Time frame |
|---|---|
| To evaluate the effect of the addition of rituximab to a standard chemotherapy regimen with respect to: 1. Response rates after (R-) MBVP, after HD-Ara-C and after completion of radiotherapy; 2. Toxicity (until 30 days after off protocol treatment); 3. Overall survival; 4. Cognitive function and quality of life after treatment. | — |
Contacts
Public ContactJ.K. Doorduijn
Erasmus MC - Daniel den Hoed Afd. Hematologie Postbus 5201
Outcome results
None listed