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NCT Number: NCT04332822

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

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.

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Key information

Conditions

DLBCL Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Border Medical Oncology Research Unit, Albury, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
  • follicular lymphoma grade 3B
  • T-cell/histiocyte-rich LBCL
  • primary cutaneous DLBCL, leg type
  • EBV-positive DLBCL, NOS
  • primary mediastinal LBCL
  • 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

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

Treatment and study plan

R-pola-mini-CHP

Drug
  • 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

R-mini-CHOP

Drug
  • 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

Primary outcomes

  1. Progression-free survival (PFS).

    Time frame: 2 years.

    Interval between randomization date and date of documented progression, first relapse, or death of any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Mats Jerkeman

CONTACT

[email protected]

0046704973507

Sponsors and collaborators

Lead sponsor

Nordic Lymphoma Group

Network

Collaborators

  • Roche Pharma AG

Registry information

Official study 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

Acronym: POLAR BEAR

Important dates

Study start
2020
Primary completion
2025
Study completion
2028
First posted
Apr 3, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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