R-MINI-CHOP versus R-MINI-CHP in combination with polatuzumab-vedotin, as primary treatment for patients with diffuse large B-cell lymphoma, =80 years, or frail =75 years – an open label randomized Nordic Lymphoma Group phase III trial - NLG-LBC7 - POLAR BEAR

Skåne University Hospital, Department of Oncology0 个研究点目标入组 200 人开始时间: 2020年5月4日最近更新: 2024年3月4日

适应症

试验速览

暂无简介。

•1.Age =80 years or frail =75 years, at the discretion of the investigator
•2.Histologically confirmed (according to the WHO classification) diffuse large B-cell lymphoma stage II-IV
•3.No previous treatment for lymphoma
•4.WHO performance status 0 – 3 (Grade 3 only if related to DLBCL)
•5.Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•1.Severe cardiac disease: NYHA grade 3-4
•2.Transformation from previously diagnosed indolent lymphoma
•3.Impaired liver (transaminases > 3x normal upper limit or bilirubin > 2,0 mg/dl unless due to Gilbert´s syndrome) , renal (GFR<50ml/min) or
•other organ function not caused by lymphoma, which will interfere with the treatment.
•4.Absolute neutrophil count (ANC) <1000 cells/?L or platelets <100,000 cells/?L, unless due to lymphoma
•5.Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and
•without relapse since 2 years, or low grade prostate cancer, not in need of treatment
•6.Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
•7.Hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, doxorubicin or bendamustine, or HACA against rituximab.
•8.Peripheral neuropathy grade = 2

发起方

Skåne University Hospital, Department of Oncology