Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
Sponsor: Nordic Lymphoma Group
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.
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
Key Details
Gender
All
Age Range
75 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2020-08-19
Completion Date
2028-12-28
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
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
Locations (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
Naples, Italy
Istituto Nazionale Tumori "Fondazione Pascale" Napoli
Naples, 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