Trial Review

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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
15/08/2024

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
The Canberra Hospital - Garran
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Liverpool - Liverpool
Recruitment hospital [8] 0 0
Bendigo - Melbourne
Recruitment hospital [9] 0 0
Northern Health - Melbourne
Recruitment hospital [10] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [11] 0 0
Western Health - Melbourne
Recruitment hospital [12] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [13] 0 0
Orange Health - Orange
Recruitment hospital [14] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [15] 0 0
Port Macquarie - Port Macquarie
Recruitment hospital [16] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [17] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [18] 0 0
Sunshine Coast University Hospital - Sunshine Coast
Recruitment hospital [19] 0 0
Tweed Hospital - Tweed Heads
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
- Garran
Recruitment postcode(s) [6] 0 0
- Hobart
Recruitment postcode(s) [7] 0 0
- Liverpool
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
- Murdoch
Recruitment postcode(s) [10] 0 0
- Orange
Recruitment postcode(s) [11] 0 0
- Perth
Recruitment postcode(s) [12] 0 0
- Port Macquarie
Recruitment postcode(s) [13] 0 0
- Randwick
Recruitment postcode(s) [14] 0 0
- St Leonards
Recruitment postcode(s) [15] 0 0
- Sunshine Coast
Recruitment postcode(s) [16] 0 0
- Tweed Heads
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04332822