Rituximab in Primary Central Nervous system Lymphoma.A randomized HOVON / ALLG intergroup study - HOVON 105 PCNS

HOVON Foundation0 个研究点目标入组 200 人开始时间: 2010年1月27日最近更新: 2016年4月18日

试验速览

暂无简介。

•- 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
•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
•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

•-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

发起方

HOVON Foundation