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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04332822




Registration number
NCT04332822
Ethics application status
Date submitted
1/04/2020
Date registered
3/04/2020
Date last updated
19/09/2024

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
NLG-LBC7 POLAR BEAR
Universal Trial Number (UTN)
Trial acronym
POLAR BEAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
DLBCL 0 0
Diffuse Large B Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - R-pola-mini-CHP
Treatment: Drugs - R-mini-CHOP

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


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS).
Timepoint [1] 0 0
2 years.

Eligibility
Key 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:

1. diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
2. follicular lymphoma grade 3B
3. T-cell/histiocyte-rich LBCL
4. primary cutaneous DLBCL, leg type
5. EBV-positive DLBCL, NOS
6. primary mediastinal LBCL
7. 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
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/12/2028
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Coffs Harbour - Coffs Harbour
Recruitment hospital [4] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [5] 0 0
Tweed Valley Hospital - Cudgen
Recruitment hospital [6] 0 0
The Canberra Hospital - Garran
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
Liverpool - Liverpool
Recruitment hospital [9] 0 0
Bendigo - Melbourne
Recruitment hospital [10] 0 0
Northern Health - Melbourne
Recruitment hospital [11] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [12] 0 0
Western Health - Melbourne
Recruitment hospital [13] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [14] 0 0
Orange Health - Orange
Recruitment hospital [15] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [16] 0 0
Port Macquarie - Port Macquarie
Recruitment hospital [17] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [18] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [19] 0 0
Sunshine Coast University Hospital - Sunshine Coast
Recruitment hospital [20] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [21] 0 0
Westmead - Westmead
Recruitment postcode(s) [1] 0 0
- Albury
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Coffs Harbour
Recruitment postcode(s) [4] 0 0
- Concord
Recruitment postcode(s) [5] 0 0
- Cudgen
Recruitment postcode(s) [6] 0 0
- Garran
Recruitment postcode(s) [7] 0 0
- Hobart
Recruitment postcode(s) [8] 0 0
- Liverpool
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
- Murdoch
Recruitment postcode(s) [11] 0 0
- Orange
Recruitment postcode(s) [12] 0 0
- Perth
Recruitment postcode(s) [13] 0 0
- Port Macquarie
Recruitment postcode(s) [14] 0 0
- Randwick
Recruitment postcode(s) [15] 0 0
- St Leonards
Recruitment postcode(s) [16] 0 0
- Sunshine Coast
Recruitment postcode(s) [17] 0 0
- Waratah
Recruitment postcode(s) [18] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aalborg
Country [2] 0 0
Denmark
State/province [2] 0 0
Aarhus
Country [3] 0 0
Denmark
State/province [3] 0 0
Copenhagen
Country [4] 0 0
Denmark
State/province [4] 0 0
Esbjerg
Country [5] 0 0
Denmark
State/province [5] 0 0
Holstebro
Country [6] 0 0
Denmark
State/province [6] 0 0
Odense
Country [7] 0 0
Denmark
State/province [7] 0 0
Roskilde
Country [8] 0 0
Denmark
State/province [8] 0 0
Vejle
Country [9] 0 0
Finland
State/province [9] 0 0
Helsinki
Country [10] 0 0
Finland
State/province [10] 0 0
Kuopio
Country [11] 0 0
Finland
State/province [11] 0 0
Oulu
Country [12] 0 0
Finland
State/province [12] 0 0
Tampere
Country [13] 0 0
Finland
State/province [13] 0 0
Turku
Country [14] 0 0
Italy
State/province [14] 0 0
Aviano
Country [15] 0 0
Italy
State/province [15] 0 0
Bari
Country [16] 0 0
Italy
State/province [16] 0 0
Calabria
Country [17] 0 0
Italy
State/province [17] 0 0
Monza
Country [18] 0 0
Italy
State/province [18] 0 0
Napoli
Country [19] 0 0
Italy
State/province [19] 0 0
Roma
Country [20] 0 0
Italy
State/province [20] 0 0
Segrate
Country [21] 0 0
Italy
State/province [21] 0 0
Trieste
Country [22] 0 0
Italy
State/province [22] 0 0
Turin
Country [23] 0 0
Italy
State/province [23] 0 0
Udine
Country [24] 0 0
Italy
State/province [24] 0 0
Verona
Country [25] 0 0
New Zealand
State/province [25] 0 0
Grafton
Country [26] 0 0
New Zealand
State/province [26] 0 0
Wellington
Country [27] 0 0
Norway
State/province [27] 0 0
Bergen
Country [28] 0 0
Norway
State/province [28] 0 0
Grålum
Country [29] 0 0
Norway
State/province [29] 0 0
Innlandet
Country [30] 0 0
Norway
State/province [30] 0 0
Oslo
Country [31] 0 0
Norway
State/province [31] 0 0
Stavanger
Country [32] 0 0
Norway
State/province [32] 0 0
Trondheim
Country [33] 0 0
Norway
State/province [33] 0 0
Tønsberg
Country [34] 0 0
Sweden
State/province [34] 0 0
Borås
Country [35] 0 0
Sweden
State/province [35] 0 0
Göteborg
Country [36] 0 0
Sweden
State/province [36] 0 0
Halmstad
Country [37] 0 0
Sweden
State/province [37] 0 0
Kalmar
Country [38] 0 0
Sweden
State/province [38] 0 0
Linköping
Country [39] 0 0
Sweden
State/province [39] 0 0
Lund
Country [40] 0 0
Sweden
State/province [40] 0 0
Stockholm
Country [41] 0 0
Sweden
State/province [41] 0 0
Södra Sunderbyn
Country [42] 0 0
Sweden
State/province [42] 0 0
Uddevalla
Country [43] 0 0
Sweden
State/province [43] 0 0
Umeå
Country [44] 0 0
Sweden
State/province [44] 0 0
Uppsala
Country [45] 0 0
Sweden
State/province [45] 0 0
Varberg
Country [46] 0 0
Sweden
State/province [46] 0 0
Örebro

Funding & Sponsors
Primary sponsor type
Other
Name
Nordic Lymphoma Group
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Roche Pharma AG
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT04332822
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mats Jerkeman
Address 0 0
Department of Oncology, Skåne University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mats Jerkeman
Address 0 0
Country 0 0
Phone 0 0
0046704973507
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04332822