A Phase 1/2 study of the combination of pixantrone, etoposide, bandamustine and, in CD-20 positive tumors, rituximab in patients with relapsed aggressive non-Hodgkin lymphomas of B- or T-cell phenotypa- 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: 2016年3月31日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•-Patients with a histologically confirmed relapse of an aggressive lymphoma of T- or B-cell phenotype (including follicar lymphoma grade 3b). For excluded hidstological entities seeExclusion Criteria
•.Phase 1 + Phase 2fit 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) and/ or
•- ECOG PS 2-3 at the protocol entry (for ECOG definition, see appendix A) and/ or
•- Deemed frail by the treating physician
•- Estimated life expectancy of 3 months or longer
•- Measurable disease
•- Hemoglobin = 8g/dL (= 5 mmol/l) (can be post transfusion)
•- Platelets = 100 x 109 / L; = 75 x 109/ L permitted if bone marrow involvement
•- Absolute netrophil 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 tranaminase (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

•- Patient swith primary refratory disease (e.g. prigressing under platinum-containing of similar salvage therapy) defined as < 6 months response duration from last given course of treatment
•- High-dose thearpy with autologous stem cell rescue within the last 6 months prior to study entry.
•- Following T-cell lymphoma entities:
•- T-cell lymphoblastic lymphoma
•- Hepatosplenic T-cell lymphoma
•- Extranodal NK/ T, nasal type
•- Subcutaneous panniculities-like
•- Primary cutaneous T-cell lymphoma
•- Primary leukemic T-cell lymphoma
•- Following B-cell lymphoma entities:
•- Transformed indolent B-cell lymphomas
•- Post-transplant B-cell lymphoproliferstive disease
•- HIV associated B-cell lymphoma
•- Concurrent severe and / or uncotrolled medical disease which is not lymphoma-related
•- Left ventricular ejection fraction (LVEF) < 45 %
•- Suspected or documented central nervous system involment By NHL.
•- Patients known to be antigen positie for HIV and / or hepatis 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 carsinoma
•- Known hypersensitivity to one or more of the study drugs
•- Unwillingness or inability to comply with the protocol

发起方

Department of Hematology, Aarhus University Hospital