Primary Central Nervous system Lymphoma MedDRA version: 18.1 Level: LLT Classification code 10036685 Term: Primary central nervous system lymphoma System Organ Class: 100000004864
Conditions
Sponsors
HOVON Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a histologically confirmed diagnosis of CD20 positive DLBCL based upon a representative histology specimen of brain biopsy according to the WHO/ECOG classification OR Patients with a diagnosis of PCNSL based on MRI evidence of brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma AND unequivocal morphological and/or immunophenotypical evidence of CSF CD20 + large cell lymphoma AND/OR unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid OR Patients with unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid AND CSF but without a brain parenchymal lesion -Age 18-70 years inclusive -Performance status with or without administration of steroids WHO 0 – 3 -Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: -Evidence of systemic lymphoma -History of intolerance of exogenous protein administration -Severe cardiac dysfunction (NYHA classification III-IV, appendix H, or LVEF < 45%) Congestive heart failure or symptomatic coronary artery disease or cardiac arythmias not well controlled with medication -Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) -Significant hepatic dysfunction (bilirubin or transaminase = 2.5 x upper normal limit). -Significant renal dysfunction (serum creatinine =150 umol/l or clearance < 60 ml/min -Presence of “third space fluid”, such as pleural effusion or ascites -Prior cranial radiotherapy -Active uncontrolled infection -HIV-positivity -(EBV positive) post-transplant lymphoproliferative disorder -Untreated hepatitis B infection (inclusion is possible if adequate antiviral medication e.g. lamivudine or alternative is started) -Positive pregnancy test in women of reproductive potential -Lactating women -Unable or unwilling to use adequate contraceptive methods (all men, pre-menopausal women) -Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the effect of the addition of rituximab to standard chemotherapy for PCNSL;Secondary Objective: To evaluate the effect of the addition of rituximab to a standard chemotherapy regimen with respect to toxicity;Primary end point(s): Event-free survival measured from the date of registration. Patients without event (an event is no CR(u) on protocol, relapse or death in CR(u)) are censored at the last day they were known to be alive.;Timepoint(s) of evaluation of this end point: At entry, before second MBVP, before HD-Ara-C, after HD-Ara-C, after radiotherapy, during FU until relapse/progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At entry, before second MBVP, before HD-Ara-C, after HD-Ara-C, after radiotherapy, during FU until relapse/progression;Secondary end point(s): - Response rates after (R-)MBVP, after HD-Ara-C and after completion of radiotherapy - Toxicity - Overall survival measured from the date of registration. Patients still alive or lost to follow up are censored at the last day they were known to be alive. - Cognitive function and quality of life after treatment | — |
Countries
Australia, Netherlands, New Zealand
Contacts
Public ContactDr. J.K. Doorduijn
HOVON Data Center
Outcome results
None listed