Rituximab in Primary Central Nervous system Lymphoma.A randomized HOVON / ALLG intergroup study

Active, not recruiting

• Conditions: Primary Central Nervous system Lymphoma; MedDRA version: 18.1Level: LLTClassification code 10036685Term: Primary central nervous system lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2009-014722-42-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-27
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified