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 - NLG-LBC7 (POLAR BEAR)

Phase 1

Active, not recruiting

• Conditions: Diffuse large B-cell lymphoma.; MedDRA version: 21.1Level: LLTClassification code 10012857Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractorySystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-003889-14-FI
• Lead Sponsor: Skåne University Hospital, Department of Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-04
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Age =80 years or frail =75 years, at the discretion of the investigator
2.Histologically confirmed (according to the WHO classification) diffuse large B-cell lymphoma stage II-IV
3.No previous treatment for lymphoma
4.WHO performance status 0 – 3 (Grade 3 only if related to DLBCL)
5.Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1.Severe cardiac disease: NYHA grade 3-4
2.Transformation from previously diagnosed indolent lymphoma
3.Impaired liver (transaminases > 3x normal upper limit or bilirubin > 2,0 mg/dl unless due to Gilbert´s syndrome) , renal (GFR<50ml/min) or
other organ function not caused by lymphoma, which will interfere with the treatment.
4.Absolute neutrophil count (ANC) <1000 cells/?L or platelets <100,000 cells/?L, unless due to lymphoma
5.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
6.Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
7.Hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, doxorubicin or bendamustine, or HACA against rituximab.
8.Peripheral neuropathy grade = 2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate if progression-free survival with pola-R-mini-CHP is superior to that of R-mini-CHOP.;Secondary Objective: To compare response duration, complete remission rate (CR), overall response rate (ORR), health-related quality of life (HRQOL), lymphoma specific survival (LSS), overall survival (OS), and safety between these regimens.;Primary end point(s): Progression-free survival:<br>This is defined as the interval between randomization date and date of documented progression, first relapse, or death of any cause. 5. Otherwise, patients will be censored at the last date they were known to be alive. <br>;Timepoint(s) of evaluation of this end point: Continuously during time from randomization, treatment phase, and follow up phase (36 month after end of treatment).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival:<br>This is defined as time from registration to death of any cause. Patients still alive or lost to follow-up are censored at the last date they were known to be alive.<br>;Timepoint(s) of evaluation of this end point: Continuously during time for registration, treatment phase, and follow up phase (36 month after end of treatment).