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 : 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

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..

Medienart:

Klinische Studie

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

ClinicalTrials.gov - (2024) vom: 13. Feb. Zur Gesamtaufnahme - year:2024

Sprache:

Englisch

Links:

Volltext [kostenfrei]

Themen:

610
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Phase: Phase 3
Recruitment Status: Recruiting
Study Type: Interventional

Anmerkungen:

Source: Link to the current ClinicalTrials.gov record., First posted: April 3, 2020, Last downloaded: ClinicalTrials.gov processed this data on February 21, 2024, Last updated: February 21, 2024

Study ID:

NCT04332822
NLG-LBC7 POLAR BEAR

Veröffentlichungen zur Studie:

fisyears:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG003349225