Actively Recruiting
R-MINI-CHOP Versus R-MINI-CHP With Polatuzumab Vedotin as First Treatment for Diffuse Large B-cell Lymphoma in Patients 80 Years or Older, or Frail 75 Years and Older
Led by Nordic Lymphoma Group · Updated on 2024-09-19
300
Participants Needed
69
Research Sites
156 weeks
Total Duration
On this page
Sponsors
N
Nordic Lymphoma Group
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial focuses on elderly patients aged 80 years or older, or those 75 years and older who are considered frail, with untreated diffuse large B-cell lymphoma (DLBCL) and related lymphoma subtypes. The study is a phase III, randomized, open-label, multicenter trial conducted in several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. It aims to compare the standard chemotherapy regimen R-miniCHOP with an experimental treatment R-pola-miniCHP, where vincristine is replaced by polatuzumab vedotin, to assess differences in outcomes for this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive R-mini-CHOP consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone over six 21-day cycles. The other group will receive R-pola-mini-CHP, which includes rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin instead of vincristine, also given over six 21-day cycles. Both treatments last approximately 18 weeks. The study includes a screening period lasting up to 4 weeks before treatment begins. During the study, participants will be followed for up to 36 months after completing treatment to monitor progression-free survival over two years. Researchers will evaluate disease progression and safety outcomes through regular assessments during and after the treatment period. Participants will provide informed consent and undergo evaluations including health status and disease measurements to ensure eligibility and monitor treatment effects throughout the trial.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 80 years or older, or 75 years and frail according to a simplified comprehensive geriatric assessment
- Histologically confirmed lymphoma subtype including diffuse large B-cell lymphoma and related types
- Stage II-IV disease
- At least one measurable site of disease larger than 1.5 cm
- No previous treatment for lymphoma
- WHO performance status between 0 and 3 (grade 3 allowed if related to lymphoma)
- Written informed consent provided
You will not qualify if you...
- Severe cardiac disease classified as NYHA grade 3 or 4
- Central nervous system involvement at diagnosis
- Uncontrolled serious infection
- Impaired liver or kidney function not caused by lymphoma that interferes with treatment
- Absolute neutrophil count below 1000 cells/µL or platelets below 100,000 cells/µL unless due to lymphoma
- Prior malignancy except non-melanoma skin cancer, stage 0 cervical carcinoma treated without relapse for 2 years, or low-grade prostate cancer not needing treatment
- Psychiatric illness interfering with study understanding
- Known hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, vincristine, doxorubicin, or rituximab antibodies
- Peripheral neuropathy grade 2 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of 21 days each)
Participants receive one of two drug regimens in cycles lasting 21 days each. Treatment includes intravenous and oral medications administered on specific days across 6 cycles.
6 treatment visits (in-person), one per cycle
Duration - Up to 2 years
Participants are monitored for disease progression and safety after treatment completion.
Regular visits for follow-up assessments
Trial Site Locations
Total: 69 locations
1
Border Medical Oncology Research Unit
Albury, Australia
Not Yet Recruiting
2
Royal Prince Alfred Hospital
Camperdown, Australia
Actively Recruiting
3
Coffs Harbour
Coffs Harbour, Australia
Not Yet Recruiting
4
Concord Repatriation General Hospital
Concord, Australia
Actively Recruiting
5
Tweed Valley Hospital
Cudgen, Australia
Not Yet Recruiting
6
The Canberra Hospital
Garran, Australia
Not Yet Recruiting
7
Royal Hobart Hospital
Hobart, Australia
Not Yet Recruiting
8
Liverpool
Liverpool, Australia
Actively Recruiting
9
Bendigo
Melbourne, Australia
Not Yet Recruiting
10
Northern Health
Melbourne, Australia
Not Yet Recruiting
11
St Vincent's Hospital Melbourne
Melbourne, Australia
Actively Recruiting
12
Western Health
Melbourne, Australia
Not Yet Recruiting
13
Fiona Stanley Hospital
Murdoch, Australia
Not Yet Recruiting
14
Orange Health
Orange, Australia
Not Yet Recruiting
15
Royal Perth Hospital
Perth, Australia
Not Yet Recruiting
16
Port Macquarie
Port Macquarie, Australia
Not Yet Recruiting
17
Prince of Wales Hospital
Randwick, Australia
Actively Recruiting
18
Royal North Shore Hospital
St Leonards, Australia
Not Yet Recruiting
19
Sunshine Coast University Hospital
Sunshine Coast, Australia
Actively Recruiting
20
Calvary Mater Newcastle
Waratah, Australia
Not Yet Recruiting
21
Westmead
Westmead, Australia
Actively Recruiting
22
Department og Hematology, Aalborg University Hospital
Aalborg, Denmark
Actively Recruiting
23
Department of Hematology, Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
24
Clinic of Hematology L-4241, Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
25
Sydvestjysk Sygehus
Esbjerg, Denmark
Actively Recruiting
26
Regionshospitalet Holstebro
Holstebro, Denmark
Actively Recruiting
27
Department of Hematology X, Odense University Hospital
Odense, Denmark
Actively Recruiting
28
Department of Hematology, Zeeland University Hospital Roskilde
Roskilde, Denmark
Actively Recruiting
29
Vejle Sygehus
Vejle, Denmark
Actively Recruiting
30
Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center
Helsinki, Finland
Actively Recruiting
31
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
32
Oulu University Hospital
Oulu, Finland
Actively Recruiting
33
Tampere University Hospital
Tampere, Finland
Actively Recruiting
34
Turku University Hospital
Turku, Finland
Actively Recruiting
35
Centro di riferimento oncologico di Aviano
Aviano, Italy
Actively Recruiting
36
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S Bari
Bari, Italy
Actively Recruiting
37
The G.O.M. Bianchi-Melacrino-Morelli in Reggio Calabria
Calabria, Italy
Not Yet Recruiting
38
Ospedale San Gerardo di Monza
Monza, Italy
Actively Recruiting
39
Azienda Ospedaliera Univeristaria Federico II di Napoli
Naples, Italy
Actively Recruiting
40
Istituto Nazionale Tumori "Fondazione Pascale" Napoli
Naples, Italy
Actively Recruiting
41
Azienda Ospedaliera San Camillo Forlanini di Roma
Roma, Italy
Actively Recruiting
42
IRCCS San Raffaele Scientific Institute
Segrate, Italy
Actively Recruiting
43
Azienda Sanitaria Universitaria Integrata di Trieste
Trieste, Italy
Actively Recruiting
44
AOU San Luigi Gonzaga - Orbassano University of Turin
Turin, Italy
Actively Recruiting
45
Azienda Sanitaria Universitaria Integrata di Udine
Udine, Italy
Actively Recruiting
46
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Actively Recruiting
47
Auckland City Hospital
Grafton, New Zealand
Not Yet Recruiting
48
Wellington Blood and Cancer Centre
Wellington, New Zealand
Not Yet Recruiting
49
Haukeland Universitetshospital
Bergen, Norway
Actively Recruiting
50
Kalnes Hospital (Østfold)
Grålum, Norway
Actively Recruiting
51
Sykehuset Innlandet
Innlandet, Norway
Actively Recruiting
52
Akershus University Hospital
Oslo, Norway
Actively Recruiting
53
Avd. for Kreftbehandling, Oslo universitetssykehus
Oslo, Norway
Actively Recruiting
54
Avdeling for Blod- og Kreftsykdommer, Stavanger Universitetssykehus
Stavanger, Norway
Actively Recruiting
55
Kreftklinikken, St Olavs Hospital
Trondheim, Norway
Actively Recruiting
56
Sykehuset i Vestfold
Tønsberg, Norway
Actively Recruiting
57
Medicinkliniken, Södra Älvsborg Sjukhus
Borås, Sweden
Actively Recruiting
58
Department of Hematology and Coagulation, Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
59
Department of Medicine, Halmstad Country Hospital
Halmstad, Sweden
Actively Recruiting
60
Department of Internal Medicine, Kalmar County Hospital
Kalmar, Sweden
Actively Recruiting
61
Hematologiska Kliniken, Universitetssjukhuset
Linköping, Sweden
Actively Recruiting
62
Department of Oncology, Skåne University Hospital
Lund, Sweden
Actively Recruiting
63
Department of Oncology, Örebro University Hospital
Örebro, Sweden
Actively Recruiting
64
Department of Medicine, Sunderbyn Hospital
Södra Sunderbyn, Sweden
Actively Recruiting
65
Center of Hematology, Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
66
Uddevalla Sjukhus
Uddevalla, Sweden
Actively Recruiting
67
Cancercentrum, Norrlands universitetsjukhus
Umeå, Sweden
Actively Recruiting
68
Department of Oncology, Uppsala Academic Hospital
Uppsala, Sweden
Actively Recruiting
69
Varberg Hospital
Varberg, Sweden
Actively Recruiting
Research Team
M
Mats Jerkeman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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