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3月24日最近更新: 2024年2月26日

适应症

试验速览

暂无简介。

•1. Age =80 years or frail =75 years, according to simplified comprehensive geriatric assessment
•2. Histologically confirmed lymphoma belonging to one of the following subtypes:
•a. diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
•b. follicular lymphoma grade 3B
•c. T-cell/histiocyte-rich LBCL
•d. primary cutaneous DLBCL, leg type
•e. EBV-positive DLBCL, NOS
•f. primary mediastinal LBCL
•g. high grade B-cell lymphoma with MYC/BCL2 rearrangement
•3. Stage II-IV disease
•4. At least 1 measurable site of disease (>1.5 cm long axis)
•5. No previous treatment for lymphoma
•6. WHO performance status 0 – 3 (Grade 3 if related to DLBCL)
•7. 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. CNS involvement at diagnosis
•3. Uncontrolled serious infection
•4. Impaired liver (transaminases >3x normal upper limit or bilirubin > 1.5 x normal upper limit, unless due to Gilbert´s syndrome), renal (GFR<30ml/min) or other organ function not caused by lymphoma, which will interfere with the treatment
•5. Absolute neutrophil count (ANC) <1000 cells/mcL or platelets <100,000 cells/mcL, unless due to lymphoma
•6. 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
•7. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study
•8. Known hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, vincristine or doxorubicin, or to additives in the formulations above, or known hypersensitivity to other human, humanized, chimeric or porcine monoclonal antibodies, or HACA against rituximab
•9. Peripheral neuropathy grade = 2

发起方

Skåne University Hospital, Department of Oncology