NCT04332822Active, not recruitingPhase 3
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Oct 2026
Brief summary (registry, in English)
The primary objective is to evaluate the efficacy of pola-R-mini-CHP in comparison with R-mini-CHOP
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 249 (estimated)
- First submitted
- 16 Jun 2023
- Start date
- 18 Aug 2020
- Lead sponsor
- Region Skane
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT04332822
- EU CT number
- 2022-502887-19-00
- EudraCT number
- 2018-003889-14
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 249
- 48 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe cardiac disease: NYHA grade 3-4
- Uncontrolled serious infection
- 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
- Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study
- 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
Lab values
- 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
- Absolute neutrophil count (ANC) <1000 cells/µL or platelets <100,000 cells/µL, unless due to lymphoma
Other
- CNS involvement at diagnosis
- Peripheral neuropathy grade ≥ 2
Who the study is looking for
- Age ≥80 years or frail ≥75 years, according to simplified comprehensive geriatric assessment
- 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
- Stage II-IV disease
- At least 1 measurable site of disease (>1.5 cm long axis)
- No previous treatment for lymphoma
- WHO performance status 0 – 3 (Grade 3 if related to DLBCL)
- Written informed consent
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Active, not recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Sydvestjysk Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Active, not recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Herning | Denmark | Active, not recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Koege | Denmark | Active, not recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Active, not recruiting |
| Vejle Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Active, not recruiting |
| North Estonia Medical Centre Foundation Coordinator of this site? Confirm its status | Tallinn | Estonia | Not yet recruiting |
| Tartu University Hospital Coordinator of this site? Confirm its status | Tartu Linn | Estonia | Not yet recruiting |
| Helsinki University Central Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Active, not recruiting |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Active, not recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Active, not recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Active, not recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Active, not recruiting |
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Active, not recruiting |
| Istituto Tumori Bari Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Active, not recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Active, not recruiting |
| Grande Ospedale Metropolitano Bianchi Melacrino Morelli Coordinator of this site? Confirm its status | Reggio Calabria | Italy | Active, not recruiting |
| San Camillo Forlanini Hospital Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina Coordinator of this site? Confirm its status | Trieste | Italy | Active, not recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Active, not recruiting |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Active, not recruiting |
| Sykehuset Innlandet HF Coordinator of this site? Confirm its status | Gjoevik | Norway | Active, not recruiting |
| Sykehuset Oestfold HF Kalnes Coordinator of this site? Confirm its status | Graalum | Norway | Active, not recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Active, not recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| Helse Stavanger HF Coordinator of this site? Confirm its status | Stavanger | Norway | Active, not recruiting |
| Vestfold Hospital Trust Coordinator of this site? Confirm its status | Tonsberg | Norway | Active, not recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Active, not recruiting |
| Sodra Alvsborg Hospital-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Boras | Sweden | Active, not recruiting |
| Sahlgrenska University Hospital-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Active, not recruiting |
| Region Halland Coordinator of this site? Confirm its status | Halmstad | Sweden | Active, not recruiting |
| Laenssjukhuset I Kalmar Region Kalmar Laen Coordinator of this site? Confirm its status | Kalmar | Sweden | Active, not recruiting |
| Linkoping University Hospital Region Ostergotland Coordinator of this site? Confirm its status | Linkoping | Sweden | Active, not recruiting |
| Region Norrbotten Coordinator of this site? Confirm its status | Lulea | Sweden | Active, not recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Active, not recruiting |
| Region Oerebro Laen Coordinator of this site? Confirm its status | Orebro | Sweden | Active, not recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Active, not recruiting |
| NU Hospital Group-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Trollhattan | Sweden | Active, not recruiting |
| Norrlands University Hospital Coordinator of this site? Confirm its status | Umeå | Sweden | Active, not recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Active, not recruiting |
| Region Halland Coordinator of this site? Confirm its status | Varberg | Sweden | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.