Polar Bear

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Skane

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

18 Aug 2020 → ongoing

Decision date (initial)

2023-07-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Roche AB

External identifiers

EU CT number

2022-502887-19-00

EudraCT number

2018-003889-14

ClinicalTrials.gov

NCT04332822

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

The primary objective is to evaluate the efficacy of pola-R-mini-CHP in comparison with R-mini-CHOP

Secondary objectives 3

1. Efficacy, through assessment of response duration, complete remission rate (CR), overall response rate (ORR), health-related quality of life (HRQOL), lymphoma specific survival (LSS), overall survival (OS)
2. Safety, through collection of adverse events and serious adverse events
3. Health related quality of life, assessed by use of the EORTC QLQ-C30 questionnaire

Conditions and MedDRA coding

Diffuse Large B-Cell Lymphoma

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age ≥80 years or frail ≥75 years, according to simplified comprehensive geriatric assessment
2. Histologically confirmed lymphoma belonging to one of the following subtypes: a. Diffuse large B-cell lymphoma, including transformation from an indolent lymphoma; b. Follicular lymphoma grade 3B; c. T-cell/histiocyte-rich LBCL; d. Primary cutaneous DLBCL, leg type; e. EBV-positive DLBCL, NOS; f. Primary mediastinal LBCL; g. High grade B-cell lymphoma with MYC/BCL2 rearrangement
3. Stage II-IV disease
4. At least 1 measurable site of disease (>1.5 cm long axis)
5. No previous treatment for lymphoma
6. WHO performance status 0 – 3 (Grade 3 if related to DLBCL)
7. Written informed consent

Exclusion criteria 9

1. Severe cardiac disease: NYHA grade 3-4
2. CNS involvement at diagnosis
3. Uncontrolled serious infection
4. 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
5. Absolute neutrophil count (ANC) <1000 cells/µL or platelets <100,000 cells/µL, unless due to lymphoma
6. 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
7. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study
8. Known hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, vincristine or doxorubicin, or to additives in the formulations above, or known hypersensitivity to other human, humanized, chimeric or porcine monoclonal antibodies, or HACA against rituximab
9. Peripheral neuropathy grade ≥ 2

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival

Secondary endpoints 7

1. Response duration
2. Complete remission rate
3. Overall response rate
4. Health-related quality of life
5. Overall survival
6. Lymphoma-specific survival
7. Safety

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Skane

Sponsor organisation

Region Skane

Address

Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri

City

Malmo

Postcode

211 74

Country

Sweden

Scientific contact point

Organisation

Region Skane

Contact name

Coordinating investigator Mats Jerkeman

Public contact point

Organisation

Region Skane

Contact name

Coordinating investigator Mats Jerkeman

Third parties 1

Locations

6 EU/EEA countries · 48 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 31 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications