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

Study Locations

  • Australia
      • 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:
        • 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
  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Department og Hematology, Aalborg University Hospital
        • Contact:
        • Principal Investigator:
          • Jakob Madsen
      • Aarhus, Denmark
        • Recruiting
        • Department of Hematology, Aarhus University Hospital
        • Contact:
        • Principal Investigator:
          • Judit Jörgensen
      • Copenhagen, Denmark
        • Recruiting
        • Clinic of Hematology L-4241, Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Peter Brown
      • Esbjerg, Denmark
        • Recruiting
        • Sydvestjysk Sygehus
        • Contact:
        • Principal Investigator:
          • Andriette Dessau-Arp
      • Holstebro, Denmark
        • Recruiting
        • Regionshospitalet Holstebro
        • Contact:
        • Principal Investigator:
          • Troels Møller Thomsen
      • Odense, Denmark
        • Recruiting
        • Department of Hematology X, Odense University Hospital
        • Contact:
        • Principal Investigator:
          • Karen Juul-Jensen
      • Roskilde, Denmark
        • Recruiting
        • Department of Hematology, Zeeland University Hospital Roskilde
        • Contact:
        • Principal Investigator:
          • Christian Bjørn Poulsen
      • Vejle, Denmark
  • Finland
      • Helsinki, Finland
        • Recruiting
        • Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Sirpa Leppä
      • Kuopio, Finland
        • Recruiting
        • Kuopio University Hospital
        • Contact:
        • Principal Investigator:
          • Katja Marin
      • Oulu, Finland
        • Recruiting
        • Oulu University Hospital
        • Contact:
        • Principal Investigator:
          • Hanne Kuitunen
      • Tampere, Finland
        • Recruiting
        • Tampere University Hospital
        • Contact:
        • Principal Investigator:
          • Marjukka Pollari
      • Turku, Finland
        • Recruiting
        • Turku University Hospital
        • Contact:
        • Principal Investigator:
          • Sirkku Jyrkkiö
  • Italy
      • Aviano, Italy
        • Recruiting
        • Centro di Riferimento Oncologico di Aviano
        • Principal Investigator:
          • Michele Spina
        • Contact:
      • Bari, Italy
        • Recruiting
        • Istituto Tumori "Giovanni Paolo II" I.R.C.C.S Bari
        • Principal Investigator:
          • Attilio Guarini
        • Contact:
      • Calabria, Italy
        • Not yet recruiting
        • The G.O.M. Bianchi-Melacrino-Morelli in Reggio Calabria
        • Contact:
        • Principal Investigator:
          • Caterina Stelitano
      • Monza, Italy
        • Recruiting
        • Ospedale San Gerardo di Monza
        • Principal Investigator:
          • Silvia Anna Maria Bolis
        • Contact:
      • Napoli, Italy
        • Recruiting
        • Azienda Ospedaliera Univeristaria Federico II di Napoli
        • Contact:
        • Principal Investigator:
          • Alessandro Pinto
      • Napoli, Italy
        • Recruiting
        • Istituto Nazionale Tumori "Fondazione Pascale" Napoli
        • Principal Investigator:
          • Antonello Pinto
        • Contact:
      • Roma, Italy
        • Recruiting
        • Azienda Ospedaliera San Camillo Forlanini di Roma
        • Contact:
        • Principal Investigator:
          • Roberta Battistini
      • Segrate, Italy
        • Recruiting
        • IRCCS San Raffaele Scientific Institute
        • Contact:
        • Principal Investigator:
          • Andrès Ferreri
      • Trieste, Italy
      • Turin, Italy
        • Recruiting
        • AOU San Luigi Gonzaga - Orbassano University of Turin
        • Contact:
        • Principal Investigator:
          • Alessandro Morotti
      • Udine, Italy
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Principal Investigator:
          • Carlo Visco
        • Contact:
  • New Zealand
      • 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
  • Norway
      • Bergen, Norway
      • Grålum, Norway
        • Recruiting
        • Kalnes Hospital (Østfold)
        • Contact:
        • Principal Investigator:
          • Dlawer Barzenje
      • Innlandet, Norway
      • Oslo, Norway
        • Recruiting
        • Akershus University Hospital
        • Contact:
        • Principal Investigator:
          • Anders Engebretsen
      • Oslo, Norway
        • Recruiting
        • Avd. for Kreftbehandling, Oslo universitetssykehus
        • Contact:
        • Principal Investigator:
          • Julian Hamfjord
      • Stavanger, Norway
        • Recruiting
        • Avdeling for Blod- og Kreftsykdommer, Stavanger Universitetssykehus
        • Contact:
        • Principal Investigator:
          • Waleed Majeed Mohammed
      • Trondheim, Norway
        • Recruiting
        • Kreftklinikken, St Olavs Hospital
        • Contact:
        • Principal Investigator:
          • Unn Merete Fagerli
      • Tønsberg, Norway
        • Recruiting
        • Sykehuset i Vestfold
        • Contact:
        • Principal Investigator:
          • Marit Rinde
  • Sweden
      • Borås, Sweden
        • Recruiting
        • Medicinkliniken, Södra Älvsborg Sjukhus
        • Contact:
        • Principal Investigator:
          • Per-Ola Andersson
      • Göteborg, Sweden
        • Recruiting
        • Department of Hematology and Coagulation, Sahlgrenska University Hospital
        • Contact:
        • Principal Investigator:
          • Mariana Villegas Scivetti
      • Halmstad, Sweden
        • Recruiting
        • Department of Medicine, Halmstad Country Hospital
        • Contact:
        • Principal Investigator:
          • Nevzeta Kuric
      • Kalmar, Sweden
        • Recruiting
        • Department of Internal Medicine, Kalmar County Hospital
        • Contact:
        • Principal Investigator:
          • Fredrik Ellin
      • Linköping, Sweden
      • Lund, Sweden
        • Recruiting
        • Department of Oncology, Skåne University Hospital
        • Contact:
        • Principal Investigator:
          • Mats Jerkeman
      • Stockholm, Sweden
        • Recruiting
        • Center of Hematology, Karolinska University Hospital
        • Contact:
        • Principal Investigator:
          • Sara Harrysson
      • Södra Sunderbyn, Sweden
        • Recruiting
        • Department of Medicine, Sunderbyn Hospital
        • Contact:
        • Principal Investigator:
          • Lena Brandefors
      • Uddevalla, Sweden
        • Recruiting
        • Uddevalla Sjukhus
        • Contact:
        • Principal Investigator:
          • Lina Wide
      • Umeå, Sweden
      • Uppsala, Sweden
        • Recruiting
        • Department of Oncology, Uppsala Academic Hospital
        • Contact:
        • Principal Investigator:
          • Hans Hagberg
      • Varberg, Sweden
      • Örebro, Sweden
        • Recruiting
        • Department of Oncology, Örebro University Hospital
        • Contact:
        • 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:

    1. diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
    2. follicular lymphoma grade 3B
    3. T-cell/histiocyte-rich LBCL
    4. primary cutaneous DLBCL, leg type
    5. EBV-positive DLBCL, NOS
    6. primary mediastinal LBCL
    7. 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

  • 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
Drug: R-mini-CHOP
  • 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
Experimental: Arm B - R-pola-mini-CHP

Cycles 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
Drug: R-pola-mini-CHP
  • 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

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

Nordic Lymphoma Group

Collaborators

Roche Pharma AG

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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