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AzTrials

DLBCLPhase 3POLAR BEARNCT04332822

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

A Phase 3 study testing R-pola-mini-CHP and R-mini-CHOP in people with DLBCL and Diffuse Large B Cell Lymphoma, run by Nordic Lymphoma Group at 69 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
DLBCL, Diffuse Large B Cell Lymphoma
What is being tested?
R-pola-mini-CHP and R-mini-CHOP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
69 sitesin 7 countries
Study dates
19 Aug 2020to 28 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

69 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Mats Jerkeman contact

0046704973507

mats.jerkeman@med.lu.se

69 sites in 7 countries

Australia21 sites, 21 recruiting

  • Border Medical Oncology Research Unit

    Albury

    Anish Puliyayil

    Anish Puliyayil

    Not yet recruiting

  • Royal Prince Alfred Hospital

    Camperdown

    Christina Brown

    Christina Brown

    Recruiting

  • Coffs Harbour

    Coffs Harbour

    Kyle Crassini

    Kyle Crassini

    Not yet recruiting

  • Concord Repatriation General Hospital

    Concord

    Emma Verner

    Emma Verner

    Recruiting

  • Tweed Valley Hospital

    Cudgen

    Alejandro Arbelaez

    Alejandro Arbelaez

    Not yet recruiting

  • The Canberra Hospital

    Garran

    Pietro Di Ciaccio

    Pietro Di Ciaccio

    Not yet recruiting

  • Royal Hobart Hospital

    Hobart

    Anna Johnston

    Anna Johnston

    Not yet recruiting

  • Liverpool

    Liverpool

    Nicholas Viiala

    Nicholas Viiala

    Recruiting

  • Bendigo

    Melbourne

    Stephen Walker

    Stephen Walker

    Not yet recruiting

  • Northern Health

    Melbourne

    Teresa Leung

    Teresa Leung

    Not yet recruiting

  • St Vincent's Hospital Melbourne

    Melbourne

    Matthew Ku, matthew.ku@svha.org.au

    Matthew Ku

    Recruiting

  • Western Health

    Melbourne

    Christopher Leow

    Christopher Leow

    Not yet recruiting

  • Fiona Stanley Hospital

    Murdoch

    Allison Barraclough

    Allison Barraclough

    Not yet recruiting

  • Orange Health

    Orange

    Charmaine Wong

    Charmaine Wong

    Not yet recruiting

  • Royal Perth Hospital

    Perth

    Michael Francis Leahy

    Michael Francis Leahy

    Not yet recruiting

  • Port Macquarie

    Port Macquarie

    Jock Simpson

    Jock Simpson

    Not yet recruiting

  • Prince of Wales Hospital

    Randwick

    Annmarie Bosco

    Annmarie Bosco

    Recruiting

  • Royal North Shore Hospital

    St Leonards

    David Kliman

    David Kliman

    Not yet recruiting

  • Sunshine Coast University Hospital

    Sunshine Coast

    Manjunath Narayana

    Manjunath Narayana

    Recruiting

  • Calvary Mater Newcastle

    Waratah

    Aung Thant

    Aung Thant

    Not yet recruiting

  • Westmead

    Westmead

    Amanda Johnston

    Amanda Johnston

    Recruiting

Other trials in Australia

Sweden13 sites, 13 recruiting

  • Medicinkliniken, Södra Älvsborg Sjukhus

    Borås

    Per-Ola Andersson, per-ola.andersson@vgregion.se

    Per-Ola Andersson

    Recruiting

  • Department of Hematology and Coagulation, Sahlgrenska University Hospital

    Gothenburg

    Mariana Villegas Scivetti, mariana.villegas@vgregion.se

    Mariana Villegas Scivetti

    Recruiting

  • Department of Medicine, Halmstad Country Hospital

    Halmstad

    Nevzeta Kuric, nevzeta.kuric@regionhalland.se

    Nevzeta Kuric

    Recruiting

  • Department of Internal Medicine, Kalmar County Hospital

    Kalmar

    Fredrik Ellin, fredrik.ellin@med.lu.se

    Fredrik Ellin

    Recruiting

  • Hematologiska Kliniken, Universitetssjukhuset

    Linköping

    Ingemar Lagerlöf, ingemar.lagerlof@regionostergotland.se

    Ingemar Lagerlöf

    Recruiting

  • Department of Oncology, Skåne University Hospital

    Lund

    Mats Jerkeman, mats.jerkeman@med.lu.se

    Mats Jerkeman

    Recruiting

  • Department of Oncology, Örebro University Hospital

    Örebro

    Urban Jerlström, urban.jerlstrom@regionorebrolan.se

    Urban Jerlström

    Recruiting

  • Department of Medicine, Sunderbyn Hospital

    Södra Sunderbyn

    Lena Brandefors, lena.brandefors@norrbotten.se

    Lena Brandefors

    Recruiting

  • Center of Hematology, Karolinska University Hospital

    Stockholm

    Sara Harrysson, sara.harrysson@sll.se

    Sara Harrysson

    Recruiting

  • Uddevalla Sjukhus

    Uddevalla

    Lina Wide, lina.wide@vgregion.se

    Lina Wide

    Recruiting

  • Cancercentrum, Norrlands universitetsjukhus

    Umeå

    Sara Sjöström, sara.sjostrom@regionvasterbotten.se

    Sara Sjöström

    Recruiting

  • Department of Oncology, Uppsala Academic Hospital

    Uppsala

    Hans Hagberg, hans.hagberg@akademiska.se

    Hans Hagberg

    Recruiting

  • Varberg Hospital

    Varberg

    Carl Simonson, Carl.Simonson@regionhalland.se

    Carl Simonsen

    Recruiting

Other trials in Sweden

Italy12 sites, 12 recruiting

  • Centro di riferimento oncologico di Aviano

    Aviano

    Michele Spina, mspina@cro.it

    Michele Spina

    Recruiting

  • Istituto Tumori "Giovanni Paolo II" I.R.C.C.S Bari

    Bari

    Attilio Guarini, attilioguarini@oncologico.bari.it

    Attilio Guarini

    Recruiting

  • The G.O.M. Bianchi-Melacrino-Morelli in Reggio Calabria

    Calabria

    Caterina Stelitano, caterinastelitano27@gmail.com

    Caterina Stelitano

    Not yet recruiting

  • Ospedale San Gerardo di Monza

    Monza

    Silvia Anna Maria Bolis, s.bolis@asst-monza.it

    Silvia Anna Maria Bolis

    Recruiting

  • Azienda Ospedaliera Univeristaria Federico II di Napoli

    Naples

    Alessandro Pinto, a.pinto@istitutotumori.na.it

    Alessandro Pinto

    Recruiting

  • Istituto Nazionale Tumori "Fondazione Pascale" Napoli

    Naples

    Antonello Pinto, a.pinto@istitutotumori.na.it

    Antonello Pinto

    Recruiting

  • Azienda Ospedaliera San Camillo Forlanini di Roma

    Roma

    Roberta Battistini, RBattistini@scamilloforlanini.rm.it

    Roberta Battistini

    Recruiting

  • IRCCS San Raffaele Scientific Institute

    Segrate

    Andres Ferreri, Ferreri.AndresJ.M@hsr.it

    Andres Ferreri

    Recruiting

  • Azienda Sanitaria Universitaria Integrata di Trieste

    Trieste

    Francesco Zaja, francesco.zaja@asuits.sanita.fvg.it

    Francesco Zaja

    Recruiting

  • AOU San Luigi Gonzaga - Orbassano University of Turin

    Turin

    Alessandro Morotti, alessandro.morotti@unito.it

    Alessandro Morotti

    Recruiting

  • Azienda Sanitaria Universitaria Integrata di Udine

    Udine

    Stefano Volpetti, stefano.volpetti@asufc.sanita.fvg.it

    Stefano Volpetti

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona

    Carlo Visco, carlo.visco@univr.it

    Carlo Visco

    Recruiting

Other trials in Italy

Denmark8 sites, 8 recruiting

  • Department og Hematology, Aalborg University Hospital

    Aalborg

    Jakob Madsen, jm@rn.dk

    Jakob Madsen

    Recruiting

  • Department of Hematology, Aarhus University Hospital

    Aarhus

    Judit Jörgensen, Judit.Joergensen@aarhus.rm.dk

    Judit Jörgensen

    Recruiting

  • Clinic of Hematology L-4241, Rigshospitalet

    Copenhagen

    Peter Brown, peter.brown@regionh.dk

    Peter Brown

    Recruiting

  • Sydvestjysk Sygehus

    Esbjerg

    Andriette Dessau-Arp, Andriette.Dessau-Arp@rsyd.dk

    Andriette Dessau-Arp

    Recruiting

  • Regionshospitalet Holstebro

    Holstebro

    Troels Møller Thomsen, trotho@rm.dk

    Troels Møller Thomsen

    Recruiting

  • Department of Hematology X, Odense University Hospital

    Odense

    Karen Juul-Jensen, karen.juul-jensen@rsyd.dk

    Karen Juul-Jensen

    Recruiting

  • Department of Hematology, Zeeland University Hospital Roskilde

    Roskilde

    Christian Bjørn Poulsen, cbpo@regionsjaelland.dk

    Christian Bjørn Poulsen

    Recruiting

  • Vejle Sygehus

    Vejle

    Michael Clausen, Michael.Roost.Clausen@rsyd.dk

    Michael Clausen

    Recruiting

Other trials in Denmark

Norway8 sites, 8 recruiting

  • Haukeland Universitetshospital

    Bergen

    Öystein Fluge, oystein.fluge@helse-bergen.no

    Öystein Fluge

    Recruiting

  • Kalnes Hospital (Østfold)

    Grålum

    Dlawer Barzenje, Dlawer.Barzenje@so-hf.no

    Dlawer Barzenje

    Recruiting

  • Sykehuset Innlandet

    Innlandet

    Arne Kolstad, Arne.Kolstad@sykehuset-innlandet.no

    Arne Kolstad

    Recruiting

  • Akershus University Hospital

    Oslo

    Anders Engebretsen, Anders.Engebretsen@ahus.no

    Anders Engebretsen

    Recruiting

  • Avd. for Kreftbehandling, Oslo universitetssykehus

    Oslo

    Julian Hamfjord, UXHAJU@ous-hf.no

    Julian Hamfjord

    Recruiting

  • Avdeling for Blod- og Kreftsykdommer, Stavanger Universitetssykehus

    Stavanger

    Waleed Majeed Mohammed, waleed.majeed.mohammed@sus.no

    Waleed Majeed Mohammed

    Recruiting

  • Sykehuset i Vestfold

    Tønsberg

    Marit Rinde, MRIN@siv.no

    Marit Rinde

    Recruiting

  • Kreftklinikken, St Olavs Hospital

    Trondheim

    Unn Merete Fagerli, unn.merete.fagerli@stolav.no

    Unn Merete Fagerli

    Recruiting

Other trials in Norway

Finland5 sites, 5 recruiting

  • Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center

    Helsinki

    Sirpa Leppä, sirpa.leppa@helsinki.fi

    Sirpa Leppä

    Recruiting

  • Kuopio University Hospital

    Kuopio

    Katja Marin, Katja.marin@kuh.fi

    Katja Marin

    Recruiting

  • Oulu University Hospital

    Oulu

    Hanne Kuitunen, hanne.kuitunen@ppshp.fi

    Hanne Kuitunen

    Recruiting

  • Tampere University Hospital

    Tampere

    Marjukka Pollari, marjukka.pollari@pshp.fi

    Marjukka Pollari

    Recruiting

  • Turku University Hospital

    Turku

    Sirkku Jyrkkiö, sirkku.jyrkkio@tyks.fi

    Sirkku Jyrkkiö

    Recruiting

Other trials in Finland

New Zealand2 sites, 2 recruiting

  • Auckland City Hospital

    Grafton

    Henry Ngu

    Henry Ngu

    Not yet recruiting

  • Wellington Blood and Cancer Centre

    Wellington

    Jina Hayden

    Jina Hayden

    Not yet recruiting

Other trials in New Zealand

About this study

Official title: 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.

Being tested
R-pola-mini-CHP, R-mini-CHOP
Keywords
DLBCL, Diffuse Large B Cell Lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-pola-mini-CHPDrug

    • Rituximab 375 mg/m2 iv, day 1, cycle 1. 1400 mg s c OR 375 mg/m2 iv cycles 2-6
    • Cyclophosphamide 400 mg/m2 iv, day 1, cycles 1-6
    • Doxorubicin 25 mg/m2 iv , day 1, cycles 1-6
    • Prednisone, 40 mg/m2 po, days 1-5, cycles 1-6 - round up to nearest 25 mg
    • Polatuzumab vedotin 1.8 mg/kg iv day 1 cycles 1-6

  • R-mini-CHOPDrug

    • Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6
    • Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6
    • Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6
    • Vincristine 1 mg i.v. (total dose), day 1, cycles 1-6
    • Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6
Study groups in NCT04332822
Study groupRoleWhat they receive
Arm A - R-mini-CHOPActive comparatorCycles 1-6, duration 21 days * Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6 * Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6 * Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6 * Vincristine 1 mg i.v. (total dose), day 1, cycles 1-6 * Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6
Receives: Drug: R-mini-CHOP
Arm B - R-pola-mini-CHPExperimentalCycles 1-6, duration 21 days * Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6 * Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6 * Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6 * Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6 * Polatuzumab vedotin 1.8 mg/kg i.v day 1 cycles 1-6
Receives: Drug: R-pola-mini-CHP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS).

    Interval between randomization date and date of documented progression, first relapse, or death of any cause

    Measured: 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2020
  2. Study start19 Aug 2020
  3. Primary completion28 Dec 2025 (estimated)
  4. Study completion28 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04332822
Sponsor's protocol ID
NLG-LBC7 POLAR BEAR
Acronym
POLAR BEAR
Status last verified
Feb 2024
First submitted
1 Apr 2020
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing R-pola-mini-CHP and R-mini-CHOP in people with DLBCL and Diffuse Large B Cell Lymphoma, run by Nordic Lymphoma Group at 69 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Australia, Sweden, Italy, Denmark, Norway and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mats Jerkeman (0046704973507, mats.jerkeman@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS). (time frame: 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04332822.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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