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)
- Conditions
- Diffuse large B-cell lymphoma.Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]MedDRA version: 21.1Level: LLTClassification code 10012857Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractorySystem Organ Class: 100000004864
- Registration Number
- EUCTR2018-003889-14-DK
- Lead Sponsor
- Skåne University Hospital, Department of Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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/?L or platelets <100,000 cells/?L, 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 HACA against rituximab.
9.Peripheral neuropathy grade = 2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method