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

Trial Details

NCT ID
NCT04332822
Phase
PHASE3
Sponsor
Nordic Lymphoma Group
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • R-pola-mini-CHP
  • R-mini-CHOP
Locations (sample)
  • Albury, Australia|-36.07482,146.92401
  • Camperdown, Australia|-33.88965,151.17642
  • Coffs Harbour, Australia|-30.29626,153.11351
  • Concord, Australia|-33.84722,151.10381
  • Cudgen, Australia|-28.26667,153.55

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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