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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (48)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aalborg University Hospital
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AalborgDenmarkActive, not recruiting
Aarhus University Hospital
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Aarhus NDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Sydvestjysk Sygehus
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EsbjergDenmarkActive, not recruiting
Region Midtjylland
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HerningDenmarkActive, not recruiting
Region Sjaelland
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KoegeDenmarkActive, not recruiting
Odense University Hospital
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Odense CDenmarkActive, not recruiting
Vejle Hospital
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VejleDenmarkActive, not recruiting
North Estonia Medical Centre Foundation
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TallinnEstoniaNot yet recruiting
Tartu University Hospital
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Tartu LinnEstoniaNot yet recruiting
Helsinki University Central Hospital
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HelsinkiFinlandActive, not recruiting
Kuopio University Hospital
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KuopioFinlandActive, not recruiting
Oulu University Hospital
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OuluFinlandActive, not recruiting
Tampere University Hospital
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TampereFinlandActive, not recruiting
Turku University Hospital
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TurkuFinlandActive, not recruiting
Centro di Riferimento Oncologico di Aviano
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AvianoItalyActive, not recruiting
Istituto Tumori Bari Giovanni Paolo II
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BariItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyActive, not recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyActive, not recruiting
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
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Reggio CalabriaItalyActive, not recruiting
San Camillo Forlanini Hospital
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RomeItalyActive, not recruiting
Azienda Sanitaria Universitaria Giuliano Isontina
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TriesteItalyActive, not recruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyActive, not recruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyActive, not recruiting
Helse Bergen HF
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BergenNorwayActive, not recruiting
Sykehuset Innlandet HF
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GjoevikNorwayActive, not recruiting
Sykehuset Oestfold HF Kalnes
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GraalumNorwayActive, not recruiting
Akershus University Hospital
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LoerenskogNorwayActive, not recruiting
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
Helse Stavanger HF
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StavangerNorwayActive, not recruiting
Vestfold Hospital Trust
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TonsbergNorwayActive, not recruiting
St. Olavs hospital HF
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TrondheimNorwayActive, not recruiting
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
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BorasSwedenActive, not recruiting
Sahlgrenska University Hospital-Vastra Gotalandsregionen
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GothenburgSwedenActive, not recruiting
Region Halland
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HalmstadSwedenActive, not recruiting
Laenssjukhuset I Kalmar Region Kalmar Laen
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KalmarSwedenActive, not recruiting
Linkoping University Hospital Region Ostergotland
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LinkopingSwedenActive, not recruiting
Region Norrbotten
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LuleaSwedenActive, not recruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenActive, not recruiting
Region Oerebro Laen
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OrebroSwedenActive, not recruiting
Karolinska University Hospital
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SolnaSwedenActive, not recruiting
NU Hospital Group-Vastra Gotalandsregionen
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TrollhattanSwedenActive, not recruiting
Norrlands University Hospital
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UmeåSwedenActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting
Region Halland
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VarbergSwedenActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.