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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: R-pola-mini-CHP, R-mini-CHOP.
- Who it may be relevant to
- Registry conditions: DLBCL, Diffuse Large B Cell Lymphoma. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Denmark, Finland, Italy, New Zealand +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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 - 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
Primary outcome measures
- Progression-free survival (PFS). [Time frame: 2 years.]
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
- Peripheral neuropathy grade ≥ 2
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 21 centers
- Border Medical Oncology Research Unit — Albury
- Royal Prince Alfred Hospital — Camperdown
- Coffs Harbour — Coffs Harbour
- Concord Repatriation General Hospital — Concord
- Tweed Valley Hospital — Cudgen
- The Canberra Hospital — Garran
- Royal Hobart Hospital — Hobart
- Liverpool — Liverpool
- … and 13 more centers
Sweden · 13 centers
- Medicinkliniken, Södra Älvsborg Sjukhus — Borås
- Department of Hematology and Coagulation, Sahlgrenska University Hospital — Gothenburg
- Department of Medicine, Halmstad Country Hospital — Halmstad
- Department of Internal Medicine, Kalmar County Hospital — Kalmar
- Hematologiska Kliniken, Universitetssjukhuset — Linköping
- Department of Oncology, Skåne University Hospital — Lund
- Department of Oncology, Örebro University Hospital — Örebro
- Department of Medicine, Sunderbyn Hospital — Södra Sunderbyn
- … and 5 more centers
Italy · 12 centers
- Centro di riferimento oncologico di Aviano — Aviano
- Istituto Tumori "Giovanni Paolo II" I.R.C.C.S Bari — Bari
- The G.O.M. Bianchi-Melacrino-Morelli in Reggio Calabria — Calabria
- Ospedale San Gerardo di Monza — Monza
- Azienda Ospedaliera Univeristaria Federico II di Napoli — Naples
- Istituto Nazionale Tumori "Fondazione Pascale" Napoli — Naples
- Azienda Ospedaliera San Camillo Forlanini di Roma — Roma
- IRCCS San Raffaele Scientific Institute — Segrate
- … and 4 more centers
Denmark · 8 centers
- Department og Hematology, Aalborg University Hospital — Aalborg
- Department of Hematology, Aarhus University Hospital — Aarhus
- Clinic of Hematology L-4241, Rigshospitalet — Copenhagen
- Sydvestjysk Sygehus — Esbjerg
- Regionshospitalet Holstebro — Holstebro
- Department of Hematology X, Odense University Hospital — Odense
- Department of Hematology, Zeeland University Hospital Roskilde — Roskilde
- Vejle Sygehus — Vejle
Norway · 8 centers
- Haukeland Universitetshospital — Bergen
- Kalnes Hospital (Østfold) — Grålum
- Sykehuset Innlandet — Innlandet
- Akershus University Hospital — Oslo
- Avd. for Kreftbehandling, Oslo universitetssykehus — Oslo
- Avdeling for Blod- og Kreftsykdommer, Stavanger Universitetssykehus — Stavanger
- Kreftklinikken, St Olavs Hospital — Trondheim
- Sykehuset i Vestfold — Tønsberg
Finland · 5 centers
- Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center — Helsinki
- Kuopio University Hospital — Kuopio
- Oulu University Hospital — Oulu
- Tampere University Hospital — Tampere
- Turku University Hospital — Turku
New Zealand · 2 centers
- Auckland City Hospital — Grafton
- Wellington Blood and Cancer Centre — Wellington
Identifiers
NCT: NCT04332822 · NLG-LBC7 POLAR BEAR