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
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
1 other identifier
interventional
300
7 countries
69
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2020
Longer than P75 for phase_3
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 3, 2020
CompletedStudy Start
First participant enrolled
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2028
ExpectedSeptember 19, 2024
February 1, 2024
5.4 years
April 1, 2020
September 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS).
Interval between randomization date and date of documented progression, first relapse, or death of any cause
2 years.
Study Arms (2)
Arm A - R-mini-CHOP
ACTIVE 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
Arm B - R-pola-mini-CHP
EXPERIMENTALCycles 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
Interventions
* 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
* 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nordic Lymphoma Grouplead
- Roche Pharma AGcollaborator
Study Sites (69)
Border Medical Oncology Research Unit
Albury, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Coffs Harbour
Coffs Harbour, Australia
Concord Repatriation General Hospital
Concord, Australia
Tweed Valley Hospital
Cudgen, Australia
The Canberra Hospital
Garran, Australia
Royal Hobart Hospital
Hobart, Australia
Liverpool
Liverpool, Australia
Bendigo
Melbourne, Australia
Northern Health
Melbourne, Australia
St Vincent's Hospital Melbourne
Melbourne, Australia
Western Health
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
Orange Health
Orange, Australia
Royal Perth Hospital
Perth, Australia
Port Macquarie
Port Macquarie, Australia
Prince of Wales Hospital
Randwick, Australia
Royal North Shore Hospital
St Leonards, Australia
Sunshine Coast University Hospital
Sunshine Coast, Australia
Calvary Mater Newcastle
Waratah, Australia
Westmead
Westmead, Australia
Department og Hematology, Aalborg University Hospital
Aalborg, Denmark
Department of Hematology, Aarhus University Hospital
Aarhus, Denmark
Clinic of Hematology L-4241, Rigshospitalet
Copenhagen, Denmark
Sydvestjysk Sygehus
Esbjerg, Denmark
Regionshospitalet Holstebro
Holstebro, Denmark
Department of Hematology X, Odense University Hospital
Odense, Denmark
Department of Hematology, Zeeland University Hospital Roskilde
Roskilde, Denmark
Vejle Sygehus
Vejle, Denmark
Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Centro di riferimento oncologico di Aviano
Aviano, Italy
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S Bari
Bari, Italy
The G.O.M. Bianchi-Melacrino-Morelli in Reggio Calabria
Calabria, Italy
Ospedale San Gerardo di Monza
Monza, Italy
Azienda Ospedaliera Univeristaria Federico II di Napoli
Napoli, Italy
Istituto Nazionale Tumori "Fondazione Pascale" Napoli
Napoli, Italy
Azienda Ospedaliera San Camillo Forlanini di Roma
Roma, Italy
IRCCS San Raffaele Scientific Institute
Segrate, Italy
Azienda Sanitaria Universitaria Integrata di Trieste
Trieste, Italy
AOU San Luigi Gonzaga - Orbassano University of Turin
Turin, Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Auckland City Hospital
Grafton, New Zealand
Wellington Blood and Cancer Centre
Wellington, New Zealand
Haukeland Universitetshospital
Bergen, Norway
Kalnes Hospital (Østfold)
Grålum, Norway
Sykehuset Innlandet
Innlandet, Norway
Akershus University Hospital
Oslo, Norway
Avd. for Kreftbehandling, Oslo universitetssykehus
Oslo, Norway
Avdeling for Blod- og Kreftsykdommer, Stavanger Universitetssykehus
Stavanger, Norway
Kreftklinikken, St Olavs Hospital
Trondheim, Norway
Sykehuset i Vestfold
Tønsberg, Norway
Medicinkliniken, Södra Älvsborg Sjukhus
Borås, Sweden
Department of Hematology and Coagulation, Sahlgrenska University Hospital
Gothenburg, Sweden
Department of Medicine, Halmstad Country Hospital
Halmstad, Sweden
Department of Internal Medicine, Kalmar County Hospital
Kalmar, Sweden
Hematologiska Kliniken, Universitetssjukhuset
Linköping, Sweden
Department of Oncology, Skåne University Hospital
Lund, Sweden
Department of Oncology, Örebro University Hospital
Örebro, Sweden
Department of Medicine, Sunderbyn Hospital
Södra Sunderbyn, Sweden
Center of Hematology, Karolinska University Hospital
Stockholm, Sweden
Uddevalla Sjukhus
Uddevalla, Sweden
Cancercentrum, Norrlands universitetsjukhus
Umeå, Sweden
Department of Oncology, Uppsala Academic Hospital
Uppsala, Sweden
Varberg Hospital
Varberg, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mats Jerkeman
Department of Oncology, Skåne University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2020
First Posted
April 3, 2020
Study Start
August 19, 2020
Primary Completion
December 28, 2025
Study Completion (Estimated)
December 28, 2028
Last Updated
September 19, 2024
Record last verified: 2024-02