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

Who is this study for? Adult patients over age 75 with diffuse large B-cell lymphoma
Status: Recruiting
Location: See all (69) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Border Medical Oncology Research Unit
NOT_YET_RECRUITING
Albury
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Coffs Harbour
NOT_YET_RECRUITING
Coffs Harbour
Concord Repatriation General Hospital
RECRUITING
Concord
Tweed Valley Hospital
NOT_YET_RECRUITING
Cudgen
The Canberra Hospital
NOT_YET_RECRUITING
Garran
Royal Hobart Hospital
NOT_YET_RECRUITING
Hobart
Liverpool
RECRUITING
Liverpool
Bendigo
NOT_YET_RECRUITING
Melbourne
Northern Health
NOT_YET_RECRUITING
Melbourne
St Vincent's Hospital Melbourne
RECRUITING
Melbourne
Western Health
NOT_YET_RECRUITING
Melbourne
Fiona Stanley Hospital
NOT_YET_RECRUITING
Murdoch
Orange Health
NOT_YET_RECRUITING
Orange
Royal Perth Hospital
NOT_YET_RECRUITING
Perth
Port Macquarie
NOT_YET_RECRUITING
Port Macquarie
Prince of Wales Hospital
RECRUITING
Randwick
Royal North Shore Hospital
NOT_YET_RECRUITING
St Leonards
Sunshine Coast University Hospital
RECRUITING
Sunshine Coast
Calvary Mater Newcastle
NOT_YET_RECRUITING
Waratah
Westmead
RECRUITING
Westmead
Denmark
Department og Hematology, Aalborg University Hospital
RECRUITING
Aalborg
Department of Hematology, Aarhus University Hospital
RECRUITING
Aarhus
Clinic of Hematology L-4241, Rigshospitalet
RECRUITING
Copenhagen
Sydvestjysk Sygehus
RECRUITING
Esbjerg
Regionshospitalet Holstebro
RECRUITING
Holstebro
Department of Hematology X, Odense University Hospital
RECRUITING
Odense
Department of Hematology, Zeeland University Hospital Roskilde
RECRUITING
Roskilde
Vejle Sygehus
RECRUITING
Vejle
Finland
Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center
RECRUITING
Helsinki
Kuopio University Hospital
RECRUITING
Kuopio
Oulu University Hospital
RECRUITING
Oulu
Tampere University Hospital
RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
Italy
Centro di riferimento oncologico di Aviano
RECRUITING
Aviano
Istituto Tumori Giovanni Paolo II I.R.C.C.S Bari
RECRUITING
Bari
The G.O.M. Bianchi-Melacrino-Morelli in Reggio Calabria
NOT_YET_RECRUITING
Calabria
Ospedale San Gerardo di Monza
RECRUITING
Monza
Azienda Ospedaliera Univeristaria Federico II di Napoli
RECRUITING
Napoli
Istituto Nazionale Tumori Fondazione Pascale Napoli
RECRUITING
Napoli
Azienda Ospedaliera San Camillo Forlanini di Roma
RECRUITING
Roma
IRCCS San Raffaele Scientific Institute
RECRUITING
Segrate
Azienda Sanitaria Universitaria Integrata di Trieste
RECRUITING
Trieste
AOU San Luigi Gonzaga - Orbassano University of Turin
RECRUITING
Turin
Azienda Sanitaria Universitaria Integrata di Udine
RECRUITING
Udine
Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING
Verona
New Zealand
Auckland City Hospital
NOT_YET_RECRUITING
Grafton
Wellington Blood and Cancer Centre
NOT_YET_RECRUITING
Wellington
Norway
Haukeland Universitetshospital
RECRUITING
Bergen
Kalnes Hospital (Østfold)
RECRUITING
Grålum
Sykehuset Innlandet
RECRUITING
Innlandet
Akershus University Hospital
RECRUITING
Oslo
Avd. for Kreftbehandling, Oslo universitetssykehus
RECRUITING
Oslo
Avdeling for Blod- og Kreftsykdommer, Stavanger Universitetssykehus
RECRUITING
Stavanger
Sykehuset i Vestfold
RECRUITING
Tønsberg
Kreftklinikken, St Olavs Hospital
RECRUITING
Trondheim
Sweden
Medicinkliniken, Södra Älvsborg Sjukhus
RECRUITING
Borås
Department of Hematology and Coagulation, Sahlgrenska University Hospital
RECRUITING
Gothenburg
Department of Medicine, Halmstad Country Hospital
RECRUITING
Halmstad
Department of Internal Medicine, Kalmar County Hospital
RECRUITING
Kalmar
Hematologiska Kliniken, Universitetssjukhuset
RECRUITING
Linköping
Department of Oncology, Skåne University Hospital
RECRUITING
Lund
Department of Oncology, Örebro University Hospital
RECRUITING
Örebro
Department of Medicine, Sunderbyn Hospital
RECRUITING
Södra Sunderbyn
Center of Hematology, Karolinska University Hospital
RECRUITING
Stockholm
Uddevalla Sjukhus
RECRUITING
Uddevalla
Cancercentrum, Norrlands universitetsjukhus
RECRUITING
Umeå
Department of Oncology, Uppsala Academic Hospital
RECRUITING
Uppsala
Varberg Hospital
RECRUITING
Varberg
Contact Information
Primary
Mats Jerkeman
mats.jerkeman@med.lu.se
0046704973507
Time Frame
Start Date: 2020-08-19
Estimated Completion Date: 2028-12-28
Participants
Target number of participants: 300
Treatments
Active_comparator: 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
Experimental: 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
Sponsors
Collaborators: Roche Pharma AG
Leads: Nordic Lymphoma Group

This content was sourced from clinicaltrials.gov

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