DRKS00017615进行中（未招募）1 期
Chemotherapy free treatment with venetoclax and obinutuzumab for relapsed /refractory primary CNS lymphoma patients (VENOBI-CNS study) – A phase IBstudy to assess the pharmacokinetics in the cerebrospinal fluid - VENOBI-CNS
Klinikum der Landeshauptstadt Stuttgart0 个研究点目标入组 5 人开始时间: 2020年1月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Age at inclusion = 18 to 80 years, in case of ECOG 0 to 1 age up to 85
- •2. Eastern Cooperative Group performance status (ECOG) = 3
- •3. Evaluable lymphoma manifestation in the CNS, either contrast-enhanced
- •lesion in the brain parenchyma or measurable meningeal lesions.
- •4. Biopsy proven CD20 positive PCNSL at initial diagnosis or previous
- •relapse/progression (re-biopsy at study inclusion is not mandatory for
- •inclusion, but strongly recommended if time in remission is longer than 24
- •5. At least one prior HD-MTX containing chemotherapy application (MTX
- •dosed at = 1 g/m2 body surface area) before progression or relapse.
- •6. Confirmed relapsed or refractory PCNSL according to the IPCG response
- •criteria with the following definition: Evidence of disease recurrence
- •following PR/CR or uCR or no radiological response (SD or PD) as per the
- •IPCG criteria to prior chemotherapy regimen(s), at least one of them
- •containing high-dose methotrexate.
- •7. Absolute neutrophil count (ANC) of at least 1’500/µl
- •8. Platelet count of at least 50’000/µl
- •9. Adequate liver (alanine aminotransferase [ALAT] and AST = 3.0 x upper
- •limit of normal [ULN] and total bilirubin = 1.5 x ULN) and kidney function
- •(estimated = 30ml/min creatinine clearance according to Cockgroft-Gault
- •10. Written informed consent
- •11. Recovery from toxicity from previous anti-lymphoma treatment to = grade 2
排除标准
- •1. Known allergy to venetoclax or other components of the formulation
- •2. Known allergy to obinutuzumab or other components of the formulation
- •3. Primary ocular lymphomas without brain parenchymal involvement
- •4. Lymphoma relapse outside the CNS; extra CNS relapse needs to be ruled
- •out by body CT scans (neck till pelvis) or PET-CT scans.
- •5. Contraindications for lumbar puncture at the discretion of the clinical
- •investigator
- •6. Prior exposure to obinutuzumab or venetoclax
- •7. Other additional anti-lymphoma treatment, e.g. chemotherapy or
- •radiotherapy
- •8. Active hepatitis B or C
- •9. HIV seropositivity
- •10. Chronic use of immunosuppressive drugs, e.g. steroids for systemic
- •autoimmune disease
- •11. Active infections requiring treatment
- •12. Other active malignancies (except non-melanoma skin cancer). Prior
- •malignancies without evidence of disease for at least 5 years are allowed
- •13. Patient is pregnant or breastfeeding, or expecting to conceive or father
- •children within one year of finishing venetoclax and 18 months for
- •obinutuzumab.
- •14. Prior allogeneic haematopoietic stem cell or solid organ transplantation
- •15. Therapeutic intervention in setting of other former interventional clinical trial
- •within 30 days before the first IMP administration in VENOBI study;
- •simultaneous participation in registry and diagnostic studies or follow up of
- •an interventional trial is allowed
- •16. Patient without legal capacity who is unable to understand the nature,
- •significance and consequences of the trial
- •17. Known or persistent abuse of medication, drugs or alcohol
- •18. Person who is in a relationship of dependence/employment with the sponsor
- •or the investigator
- •19. Administration of moderate or strong CYP3A inhibitors or inducers within 1
- •week of initiation of venetoclax dosing.
研究者
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