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
NCT ID: NCT04332822
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2020-08-19
2028-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
75 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Nordic Lymphoma Group
NETWORK
Responsible Party
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Principal Investigators
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Mats Jerkeman
Role: PRINCIPAL_INVESTIGATOR
Department of Oncology, Skåne University Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Anish Puliyayil
Role: primary
Christina Brown
Role: primary
Kyle Crassini
Role: primary
Emma Verner
Role: primary
Alejandro Arbelaez
Role: primary
Pietro Di Ciaccio
Role: primary
Anna Johnston
Role: primary
Nicholas Viiala
Role: primary
Stephen Walker
Role: primary
Teresa Leung
Role: primary
Christopher Leow
Role: primary
Allison Barraclough
Role: primary
Charmaine Wong
Role: primary
Michael Francis Leahy
Role: primary
Jock Simpson
Role: primary
Annmarie Bosco
Role: primary
David Kliman
Role: primary
Manjunath Narayana
Role: primary
Aung Thant
Role: primary
Amanda Johnston
Role: primary
Henry Ngu
Role: primary
Jina Hayden
Role: primary
Other Identifiers
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NLG-LBC7 POLAR BEAR
Identifier Type: -
Identifier Source: org_study_id
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