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)
DLBCL, Diffuse Large B Cell Lymphoma
About this trial
This is an interventional treatment trial for DLBCL focused on measuring DLBCL, Diffuse Large B Cell Lymphoma
Eligibility Criteria
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:
- 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
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
Sites / Locations
- Department og Hematology, Aalborg University HospitalRecruiting
- Department of Hematology, Aarhus University HospitalRecruiting
- Clinic of Hematology L-4241, RigshospitaletRecruiting
- Sydvestjysk SygehusRecruiting
- Herlev HospitalRecruiting
- Regionshospitalet HolstebroRecruiting
- Department of Hematology X, Odense University HospitalRecruiting
- Department of Hematology, Zeeland University Hospital RoskildeRecruiting
- Vejle SygehusRecruiting
- Department of Hematology, Helsinki University Hospital Comprehensive Cancer CenterRecruiting
- Kuopio University HospitalRecruiting
- Oulu University HospitalRecruiting
- Tampere University HospitalRecruiting
- Turku University HospitalRecruiting
- Centro di riferimento oncologico di AvianoRecruiting
- Istituto Tumori "Giovanni Paolo II" I.R.C.C.S BariRecruiting
- Ospedale San Gerardo di MonzaRecruiting
- Azienda Ospedaliera Univeristaria Federico II di NapoliRecruiting
- Istituto Nazionale Tumori "Fondazione Pascale" NapoliRecruiting
- Azienda Ospedaliera San Camillo Forlanini di RomaRecruiting
- IRCCS San Raffaele Scientific InstituteRecruiting
- Azienda Sanitaria Universitaria Integrata di TriesteRecruiting
- Azienda Sanitaria Universitaria Integrata di UdineRecruiting
- Azienda Ospedaliera Universitaria Integrata VeronaRecruiting
- Haukeland UniversitetshospitalRecruiting
- Kalnes Hospital (Østfold)Recruiting
- Akershus University HospitalRecruiting
- Avd. for Kreftbehandling, Oslo universitetssykehusRecruiting
- Avdeling for Blod- og Kreftsykdommer, Stavanger UniversitetssykehusRecruiting
- University Hospital of North NorwayRecruiting
- Kreftklinikken, St Olavs HospitalRecruiting
- Sykehuset i VestfoldRecruiting
- Medicinkliniken, Södra Älvsborg SjukhusRecruiting
- Department of Hematology and Coagulation, Sahlgrenska University HospitalRecruiting
- Department of Medicine, Halmstad Country HospitalRecruiting
- Department of Internal Medicine, Kalmar County HospitalRecruiting
- Hematologiska Kliniken, UniversitetssjukhusetRecruiting
- Department of Oncology, Skåne University HospitalRecruiting
- Center of Hematology, Karolinska University HospitalRecruiting
- Department of Medicine, Sunderbyn HospitalRecruiting
- Uddevalla SjukhusRecruiting
- Cancercentrum, Norrlands universitetsjukhusRecruiting
- Department of Oncology, Uppsala Academic HospitalRecruiting
- Varberg HospitalRecruiting
- Department of Oncology, Örebro University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A - R-mini-CHOP
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 Vincristine 1 mg i.v. (total dose), day 1, cycles 1-6 Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6
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