- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04332822
A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma (POLAR BEAR)
February 9, 2024 updated by: Nordic Lymphoma Group
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
This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell lymphoma.
Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment.
Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin.
The duration of the screening period is up to 4 weeks.
The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment.
Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2027.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mats Jerkeman
- Phone Number: 0046704973507
- Email: mats.jerkeman@med.lu.se
Study Locations
-
-
-
Albury, Australia
- Not yet recruiting
- Border Medical Oncology Research Unit
-
Contact:
- Anish Puliyayil
-
Principal Investigator:
- Anish Puliyayil
-
Camperdown, Australia
- Not yet recruiting
- Royal Prince Alfred Hospital
-
Contact:
- Christina Brown
-
Principal Investigator:
- Christina Brown
-
Coffs Harbour, Australia
- Not yet recruiting
- Coffs Harbour
-
Contact:
- Kyle Crassini
-
Principal Investigator:
- Kyle Crassini
-
Concord, Australia
- Not yet recruiting
- Concord Repatriation General Hospital
-
Principal Investigator:
- Emma Verner
-
Contact:
- Emma Verner
-
Garran, Australia
- Not yet recruiting
- The Canberra Hospital
-
Contact:
- Pietro Di Ciaccio
-
Principal Investigator:
- Pietro Di Ciaccio
-
Hobart, Australia
- Not yet recruiting
- Royal Hobart Hospital
-
Principal Investigator:
- Anna Johnston
-
Contact:
- Anna Johnston
-
Liverpool, Australia
- Not yet recruiting
- Liverpool
-
Contact:
- Nicholas Viiala
-
Principal Investigator:
- Nicholas Viiala
-
Melbourne, Australia
- Recruiting
- St Vincent's Hospital Melbourne
-
Contact:
- Matthew Ku
- Email: matthew.ku@svha.org.au
-
Principal Investigator:
- Matthew Ku
-
Melbourne, Australia
- Not yet recruiting
- Bendigo
-
Contact:
- Stephen Walker
-
Principal Investigator:
- Stephen Walker
-
Melbourne, Australia
- Not yet recruiting
- Northern Health
-
Contact:
- Teresa Leung
-
Principal Investigator:
- Teresa Leung
-
Melbourne, Australia
- Not yet recruiting
- Western Health
-
Contact:
- Christopher Leow
-
Principal Investigator:
- Christopher Leow
-
Murdoch, Australia
- Not yet recruiting
- Fiona Stanley Hospital
-
Principal Investigator:
- Allison Barraclough
-
Contact:
- Allison Barraclough
-
Orange, Australia
- Not yet recruiting
- Orange Health
-
Contact:
- Charmaine Wong
-
Principal Investigator:
- Charmaine Wong
-
Perth, Australia
- Not yet recruiting
- Royal Perth Hospital
-
Contact:
- Michael Francis Leahy
-
Principal Investigator:
- Michael Francis Leahy
-
Port Macquarie, Australia
- Not yet recruiting
- Port Macquarie
-
Principal Investigator:
- Jock Simpson
-
Contact:
- Jock Simpson
-
Randwick, Australia
- Not yet recruiting
- Prince of Wales Hospital
-
Contact:
- Annmarie Bosco
-
Principal Investigator:
- Annmarie Bosco
-
St Leonards, Australia
- Not yet recruiting
- Royal North Shore Hospital
-
Contact:
- David Kliman
-
Principal Investigator:
- David Kliman
-
Sunshine Coast, Australia
- Not yet recruiting
- Sunshine Coast University Hospital
-
Contact:
- Manjunath Narayana
-
Principal Investigator:
- Manjunath Narayana
-
Tweed Heads, Australia
- Not yet recruiting
- Tweed Hospital
-
Contact:
- Alejandro Arbelaez
-
Principal Investigator:
- Alejandro Arbelaez
-
Waratah, Australia
- Not yet recruiting
- Calvary Mater Newcastle
-
Contact:
- Aung Thant
-
Principal Investigator:
- Aung Thant
-
Westmead, Australia
- Not yet recruiting
- Westmead
-
Contact:
- Amanda Johnston
-
Principal Investigator:
- Amanda Johnston
-
-
-
-
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Aalborg, Denmark
- Recruiting
- Department og Hematology, Aalborg University Hospital
-
Contact:
- Jakob Madsen
- Email: jm@rn.dk
-
Principal Investigator:
- Jakob Madsen
-
Aarhus, Denmark
- Recruiting
- Department of Hematology, Aarhus University Hospital
-
Contact:
- Judit Jörgensen
- Email: Judit.Joergensen@aarhus.rm.dk
-
Principal Investigator:
- Judit Jörgensen
-
Copenhagen, Denmark
- Recruiting
- Clinic of Hematology L-4241, Rigshospitalet
-
Contact:
- Peter Brown
- Email: peter.brown@regionh.dk
-
Principal Investigator:
- Peter Brown
-
Esbjerg, Denmark
- Recruiting
- Sydvestjysk Sygehus
-
Contact:
- Andriette Dessau-Arp
- Email: Andriette.Dessau-Arp@rsyd.dk
-
Principal Investigator:
- Andriette Dessau-Arp
-
Holstebro, Denmark
- Recruiting
- Regionshospitalet Holstebro
-
Contact:
- Troels Møller Thomsen
- Email: trotho@rm.dk
-
Principal Investigator:
- Troels Møller Thomsen
-
Odense, Denmark
- Recruiting
- Department of Hematology X, Odense University Hospital
-
Contact:
- Karen Juul-Jensen
- Email: karen.juul-jensen@rsyd.dk
-
Principal Investigator:
- Karen Juul-Jensen
-
Roskilde, Denmark
- Recruiting
- Department of Hematology, Zeeland University Hospital Roskilde
-
Contact:
- Christian Bjørn Poulsen
- Email: cbpo@regionsjaelland.dk
-
Principal Investigator:
- Christian Bjørn Poulsen
-
Vejle, Denmark
- Recruiting
- Vejle Sygehus
-
Contact:
- Michael Clausen
- Email: Michael.Roost.Clausen@rsyd.dk
-
Principal Investigator:
- Michael Clausen
-
-
-
-
-
Helsinki, Finland
- Recruiting
- Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center
-
Contact:
- Sirpa Leppä
- Email: sirpa.leppa@helsinki.fi
-
Principal Investigator:
- Sirpa Leppä
-
Kuopio, Finland
- Recruiting
- Kuopio University Hospital
-
Contact:
- Katja Marin
- Email: Katja.marin@kuh.fi
-
Principal Investigator:
- Katja Marin
-
Oulu, Finland
- Recruiting
- Oulu University Hospital
-
Contact:
- Hanne Kuitunen
- Email: hanne.kuitunen@ppshp.fi
-
Principal Investigator:
- Hanne Kuitunen
-
Tampere, Finland
- Recruiting
- Tampere University Hospital
-
Contact:
- Marjukka Pollari
- Email: marjukka.pollari@pshp.fi
-
Principal Investigator:
- Marjukka Pollari
-
Turku, Finland
- Recruiting
- Turku University Hospital
-
Contact:
- Sirkku Jyrkkiö
- Email: sirkku.jyrkkio@tyks.fi
-
Principal Investigator:
- Sirkku Jyrkkiö
-
-
-
-
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Aviano, Italy
- Recruiting
- Centro di Riferimento Oncologico di Aviano
-
Principal Investigator:
- Michele Spina
-
Contact:
- Michele Spina
- Email: mspina@cro.it
-
Bari, Italy
- Recruiting
- Istituto Tumori "Giovanni Paolo II" I.R.C.C.S Bari
-
Principal Investigator:
- Attilio Guarini
-
Contact:
- Attilio Guarini
- Email: attilioguarini@oncologico.bari.it
-
Calabria, Italy
- Not yet recruiting
- The G.O.M. Bianchi-Melacrino-Morelli in Reggio Calabria
-
Contact:
- Caterina Stelitano
- Email: caterinastelitano27@gmail.com
-
Principal Investigator:
- Caterina Stelitano
-
Monza, Italy
- Recruiting
- Ospedale San Gerardo di Monza
-
Principal Investigator:
- Silvia Anna Maria Bolis
-
Contact:
- Silvia Anna Maria Bolis
- Email: s.bolis@asst-monza.it
-
Napoli, Italy
- Recruiting
- Azienda Ospedaliera Univeristaria Federico II di Napoli
-
Contact:
- Alessandro Pinto
- Email: a.pinto@istitutotumori.na.it
-
Principal Investigator:
- Alessandro Pinto
-
Napoli, Italy
- Recruiting
- Istituto Nazionale Tumori "Fondazione Pascale" Napoli
-
Principal Investigator:
- Antonello Pinto
-
Contact:
- Antonello Pinto
- Email: a.pinto@istitutotumori.na.it
-
Roma, Italy
- Recruiting
- Azienda Ospedaliera San Camillo Forlanini di Roma
-
Contact:
- Roberta Battistini
- Email: RBattistini@scamilloforlanini.rm.it
-
Principal Investigator:
- Roberta Battistini
-
Segrate, Italy
- Recruiting
- IRCCS San Raffaele Scientific Institute
-
Contact:
- Andres Ferreri
- Email: Ferreri.AndresJ.M@hsr.it
-
Principal Investigator:
- Andrès Ferreri
-
Trieste, Italy
- Recruiting
- Azienda Sanitaria Universitaria Integrata di Trieste
-
Principal Investigator:
- Francesco Zaja
-
Contact:
- Francesco Zaja
- Email: francesco.zaja@asuits.sanita.fvg.it
-
Turin, Italy
- Recruiting
- AOU San Luigi Gonzaga - Orbassano University of Turin
-
Contact:
- Alessandro Morotti
- Email: alessandro.morotti@unito.it
-
Principal Investigator:
- Alessandro Morotti
-
Udine, Italy
- Recruiting
- Azienda Sanitaria Universitaria Integrata di Udine
-
Principal Investigator:
- Stefano Volpetti
-
Contact:
- Stefano Volpetti
- Email: stefano.volpetti@asufc.sanita.fvg.it
-
Verona, Italy
- Recruiting
- Azienda Ospedaliera Universitaria Integrata Verona
-
Principal Investigator:
- Carlo Visco
-
Contact:
- Carlo Visco
- Email: carlo.visco@univr.it
-
-
-
-
-
Grafton, New Zealand
- Not yet recruiting
- Auckland City Hospital
-
Contact:
- Henry Ngu
-
Principal Investigator:
- Henry Ngu
-
Wellington, New Zealand
- Not yet recruiting
- Wellington Blood and Cancer Centre
-
Contact:
- Jina Hayden
-
Principal Investigator:
- Jina Hayden
-
-
-
-
-
Bergen, Norway
- Recruiting
- Haukeland Universitetshospital
-
Contact:
- Öystein Fluge
- Email: oystein.fluge@helse-bergen.no
-
Principal Investigator:
- Öystein Fluge
-
Grålum, Norway
- Recruiting
- Kalnes Hospital (Østfold)
-
Contact:
- Dlawer Barzenje
- Email: Dlawer.Barzenje@so-hf.no
-
Principal Investigator:
- Dlawer Barzenje
-
Innlandet, Norway
- Recruiting
- Sykehuset Innlandet
-
Contact:
- Arne Kolstad
- Email: Arne.Kolstad@sykehuset-innlandet.no
-
Principal Investigator:
- Arne Kolstad
-
Oslo, Norway
- Recruiting
- Akershus University Hospital
-
Contact:
- Anders Engebretsen
- Email: Anders.Engebretsen@ahus.no
-
Principal Investigator:
- Anders Engebretsen
-
Oslo, Norway
- Recruiting
- Avd. for Kreftbehandling, Oslo universitetssykehus
-
Contact:
- Julian Hamfjord
- Email: UXHAJU@ous-hf.no
-
Principal Investigator:
- Julian Hamfjord
-
Stavanger, Norway
- Recruiting
- Avdeling for Blod- og Kreftsykdommer, Stavanger Universitetssykehus
-
Contact:
- Waleed Majeed Mohammed
- Email: waleed.majeed.mohammed@sus.no
-
Principal Investigator:
- Waleed Majeed Mohammed
-
Trondheim, Norway
- Recruiting
- Kreftklinikken, St Olavs Hospital
-
Contact:
- Unn Merete Fagerli
- Email: unn.merete.fagerli@stolav.no
-
Principal Investigator:
- Unn Merete Fagerli
-
Tønsberg, Norway
- Recruiting
- Sykehuset i Vestfold
-
Contact:
- Marit Rinde
- Email: MRIN@siv.no
-
Principal Investigator:
- Marit Rinde
-
-
-
-
-
Borås, Sweden
- Recruiting
- Medicinkliniken, Södra Älvsborg Sjukhus
-
Contact:
- Per-Ola Andersson
- Email: per-ola.andersson@vgregion.se
-
Principal Investigator:
- Per-Ola Andersson
-
Göteborg, Sweden
- Recruiting
- Department of Hematology and Coagulation, Sahlgrenska University Hospital
-
Contact:
- Mariana Villegas Scivetti
- Email: mariana.villegas@vgregion.se
-
Principal Investigator:
- Mariana Villegas Scivetti
-
Halmstad, Sweden
- Recruiting
- Department of Medicine, Halmstad Country Hospital
-
Contact:
- Nevzeta Kuric
- Email: nevzeta.kuric@regionhalland.se
-
Principal Investigator:
- Nevzeta Kuric
-
Kalmar, Sweden
- Recruiting
- Department of Internal Medicine, Kalmar County Hospital
-
Contact:
- Fredrik Ellin
- Email: fredrik.ellin@med.lu.se
-
Principal Investigator:
- Fredrik Ellin
-
Linköping, Sweden
- Recruiting
- Hematologiska Kliniken, Universitetssjukhuset
-
Contact:
- Ingemar Lagerlöf
- Email: ingemar.lagerlof@regionostergotland.se
-
Principal Investigator:
- Ingemar Lagerlöf
-
Lund, Sweden
- Recruiting
- Department of Oncology, Skåne University Hospital
-
Contact:
- Mats Jerkeman
- Email: mats.jerkeman@med.lu.se
-
Principal Investigator:
- Mats Jerkeman
-
Stockholm, Sweden
- Recruiting
- Center of Hematology, Karolinska University Hospital
-
Contact:
- Sara Harrysson
- Email: sara.harrysson@sll.se
-
Principal Investigator:
- Sara Harrysson
-
Södra Sunderbyn, Sweden
- Recruiting
- Department of Medicine, Sunderbyn Hospital
-
Contact:
- Lena Brandefors
- Email: lena.brandefors@norrbotten.se
-
Principal Investigator:
- Lena Brandefors
-
Uddevalla, Sweden
- Recruiting
- Uddevalla Sjukhus
-
Contact:
- Lina Wide
- Email: lina.wide@vgregion.se
-
Principal Investigator:
- Lina Wide
-
Umeå, Sweden
- Recruiting
- Cancercentrum, Norrlands universitetsjukhus
-
Contact:
- Sara Sjöström
- Email: sara.sjostrom@regionvasterbotten.se
-
Principal Investigator:
- Sara Sjöström
-
Uppsala, Sweden
- Recruiting
- Department of Oncology, Uppsala Academic Hospital
-
Contact:
- Hans Hagberg
- Email: hans.hagberg@akademiska.se
-
Principal Investigator:
- Hans Hagberg
-
Varberg, Sweden
- Recruiting
- Varberg Hospital
-
Contact:
- Carl Simonson
- Email: Carl.Simonson@regionhalland.se
-
Principal Investigator:
- Carl Simonsen
-
Örebro, Sweden
- Recruiting
- Department of Oncology, Örebro University Hospital
-
Contact:
- Urban Jerlström
- Email: urban.jerlstrom@regionorebrolan.se
-
Principal Investigator:
- Urban Jerlström
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥80 years or frail ≥75 years, according to simplified comprehensive geriatric assessment
Histologically confirmed lymphoma belonging to one of the following subtypes:
- diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
- follicular lymphoma grade 3B
- T-cell/histiocyte-rich LBCL
- primary cutaneous DLBCL, leg type
- EBV-positive DLBCL, NOS
- primary mediastinal LBCL
- 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
Exclusion Criteria:
- Severe cardiac disease: NYHA grade 3-4
- CNS involvement at diagnosis
- Uncontrolled serious infection
- 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
- 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 HACA against rituximab
- Peripheral neuropathy grade ≥ 2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A - R-mini-CHOP
Cycles 1-6, duration 21 days
|
|
Experimental: Arm B - R-pola-mini-CHP
Cycles 1-6, duration 21 days
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS).
Time Frame: 2 years.
|
Interval between randomization date and date of documented progression, first relapse, or death of any cause
|
2 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mats Jerkeman, Department of Oncology, Skåne University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 19, 2020
Primary Completion (Estimated)
December 28, 2025
Study Completion (Estimated)
December 28, 2028
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
April 1, 2020
First Posted (Actual)
April 3, 2020
Study Record Updates
Last Update Posted (Estimated)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 9, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NLG-LBC7 POLAR BEAR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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