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)

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003889-14-SE

Enrollment

200

Registered

2019-10-22

Start date

2020-04-07

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse large B-cell lymphoma. MedDRA version: 21.1 Level: LLT Classification code 10012857 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory System Organ Class: 100000004864

Interventions

Trade Name: Polivy Product Name: polatuzumab vedotin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: POLATUZUMAB VEDOTIN Current Sponsor code: F. Hoffman la Roche Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to evaluate if progression-free survival with pola-R-mini-CHP is superior to that of R-mini-CHOP.;Secondary Objective: To compare response duration, complete remission rate (CR), overall response rate (ORR), health-related quality of life (HRQOL), lymphoma specific survival (LSS), overall survival (OS), and safety between these regimens.;Primary end point(s): Progression-free survival: This is defined as the interval between randomization date and date of documented progression, first relapse, or death of any cause. Otherwise, patients will be censored at the last date they were known to be alive. ;Timepoint(s) of evaluation of this end point: Continuously during time from randomization, treatment phase, and follow up phase (36 month after end of treatment).	—

Measure

Time frame

Main Objective: The primary objective is to evaluate if progression-free survival with pola-R-mini-CHP is superior to that of R-mini-CHOP.;Secondary Objective: To compare response duration, complete remission rate (CR), overall response rate (ORR), health-related quality of life (HRQOL), lymphoma specific survival (LSS), overall survival (OS), and safety between these regimens.;Primary end point(s): Progression-free survival: This is defined as the interval between randomization date and date of documented progression, first relapse, or death of any cause. Otherwise, patients will be censored at the last date they were known to be alive. ;Timepoint(s) of evaluation of this end point: Continuously during time from randomization, treatment phase, and follow up phase (36 month after end of treatment).

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Secondary

Measure	Time frame
Secondary end point(s): 1. Response duration 2. Complete remission rate 3. Overall remission rate 4. Health-related qualirt of life 5. Overall survival 6. Lymphoma-special survival 7. Safety ;Timepoint(s) of evaluation of this end point: Continuously during time for registration, treatment phase, and follow up phase (36 month after end of treatment).	—

Countries

Denmark, Finland, Italy, Norway, Sweden

Contacts

Public ContactClinical Trial Office

Nordic Lymphoma Group, Dept. of Haematology

a-cto@auh.rm.dk+45 7845 5855

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026