EUCTR2015-000758-39-NO进行中（未招募）1 期
A phase 1/2 study of the combination of pixantrone, etoposide, bendamustine and, in CD-20 positive tumors, rituximab in patients with relapsed aggressive non-Hodgkin lymphomas of B- or T-cell phenotype - the P[R]EBEN study - P[R]EBE
Department of Hematology, Aarhus University Hospital0 个研究点目标入组 84 人开始时间: 2017年1月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
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
- •Patients with a histologically confirmed relapse of an aggressive lymphoma of T- or B-cell phenotype (including follicular lymphoma grade 3b). For excluded histological entities see ‘Exclusion Criteria’
- •Phase 1 + Phase 2 ‘fit’ patients:
- •-Age 18-70 years at the time of inclusion
- •-ECOG performance score (PS) 0-1 at protocol entry (for ECOG definition see appendix A)
- •-Deemed ‘fit’ by the treating physician
- •Phase 2 ‘frail’ patients:
- •-Age 71-85 years at the time of inclusion
- •-ECOG PS 2-3 at protocol entry (for ECOG definition see appendix A)
- •-Deemed ‘frail’ by the treating physician
- •Estimated life expectancy of 3 months or longer
- •Measurable disease
- •Hemoglobin = 8 g/dL (=5 mmol/l) (can be post transfusion)
- •Platelets = 100 x 109/L; = 75 x 109/L permitted if bone marrow involvement
- •Absolute neutrophil count = 1.5 x 109/L; = 1.0 x 109/L permitted if documented bone marrow involvement
- •Serum bilirubin = 1.5 x upper limit of normal (ULN); patients with proven Gilbert’s syndrome (= 5 x ULN) may be enrolled.
- •Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) = 2.5 x ULN, or = 5 x ULN if elevation is due to hepatic involvement by lymphoma
- •Serum creatinine = 2 x ULN
- •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 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •Patients with primary refractory disease (e.g. progressing under platinum-containing or similar salvage therapy) defined as < 6 months response duration from last given course of treatment.
- •High-dose therapy with autologous stem cell rescue within the last 6 months prior to study entry.
- •Following T-cell lymphoma entities:
- •oT-cell lymphoblastic lymphoma
- •oHepatosplenic T-cell lymphoma
- •oExtranodal NK/T, nasal type
- •oSubcutaneous panniculitis-like
- •oPrimary cutaneous T-cell lymphoma
- •oPrimary leukemic T-cell lymphoma
- •Following B-cell lymphoma entities:
- •oTransformed indolent B-cell lymphomas
- •oPost-transplant B-cell lymphoproliferative disease
- •oHIV-associated B-cell lymphoma
- •Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
- •Left ventricular ejection fraction (LVEF) < 45%
- •Suspected or documented central nervous system involvement by NHL
- •Patients known to be antigen positive for HIV and/or hepatitis B and/or hepatitis C
- •Patients with active, uncontrolled infections
- •History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
- •Known hypersensitivity to one or more of the study drugs
- •Unwillingness or inability to comply with the protocol
研究者
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