EUCTR2006-007083-28-NL进行中（未招募）不适用
Phase II study on the feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma having achieved partial or complete remission after induction with R-PECC chemotherapy. - HOVON 85 NH
HOVON foundation0 个研究点目标入组 60 人开始时间: 2008年3月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Eligibility criteria for registration, Inclusion criteria R-PECC induction:
- •- Histologically confirmed aggressive B-cell NHL according to the World Health Organization (WHO) classification (see appendix A): Follicular lymphoma grade 3b, Diffuse large B-cell lymphoma
- •- Refractory disease or histologically confirmed first or second relapse
- •(Refractory is defined as no response or partial remission according to CT. Patients in partial
- •response (PR) can only be included in case of positive PET scan or positive biopsy)
- •- CD20 positive (assessed at 1st diagnosis or from fresh histology at confirmation of relapse or immunophenotyping of circulating CD20-positive NHL cells from peripheral blood)
- •- Current measurable disease, i.e. measurable in two perpendicular dimensions on physical examination or computerized tomography (CT) scan using standardized response criteria for NHL (Cheson et al21, 1999) (see appendix B)
- •- Age > 18 years
- •- WHO performance status 0, 1 or 2 (see appendix E)
- •- Life expectancy of at least 3 months
- •- Absolute neutrophil count > 1.5 x 109/l and platelet count > 100 x 109/l (unless caused by NHL infiltration in the bone marrow)
- •- 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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Eligibility criteria for registration, Exclusion criteria R-PECC induction:
- •- Prior allogeneic stem cell transplantation
- •- Prior radioimmunotherapy
- •- Patients who have received chemotherapy or radiotherapy within 6 weeks prior to study entry or who have not recovered from toxicities related to prior therapies
- •- Eligibility for ASCT
- •- ASCT within 12 months of study entry
- •- Investigational drugs within 4 weeks prior to entry on this study or persistent toxic side effects of such therapy
- •- Treatment with external-beam radiation therapy to more than 25% of active bone marrow (see appendix F)
- •- A history of intolerance to rituximab
- •- Severe cardiac, pulmonary, neurological, psychiatric or metabolic disease which could compromise participation in the study, or serious underlying medical conditions which could impair the ability of the patient to participate in the trial
- •- Hepatic dysfunction, bilirubin or transaminases = 2.5 x upper normal limit (unless caused by the NHL)
- •- Renal dysfunction, serum creatinine = 180 µmol/l or clearance = 40 ml/min (unless caused by the NHL)
- •- Active uncontrolled infections
- •- Patients known to be HIV-positive
- •- Current or chronic hepatitis B or hepatitis C infection
- •- Symptomatic NHL localization in the central nervous system (CNS). Lumbal puncture is not required unless CNS involvement with NHL is clinically suspected
- •- Transformed indolent lymphoma
- •- Post-transplant lymphoproliferative disorder
- •- Pregnant or breast-feeding female patients. Negative serum pregnancy test at study is mandatory for female patients of childbearing potential
研究者
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