BENITIONSClinical Trial Intelligence

A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Фаза 3 Идёт, набор закрыт NCT05171647

ЗаболеваниеNon-Hodgkin Lymphoma
ФазаФаза 3
СпонсорHoffmann-La Roche
СтатусИдёт, набор закрыт
Участники208 участн.
ВмешательствоMosunetuzumab, Polatuzumab vedotin, Tocilizumab, Rituximab, Gemcitabine
Дата начала25.04.2022
Дата завершения17.02.2025
Публикация результатов6.03.2026

Кратко

This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).

Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP)

Up to approximately 23.8 months · percentage of participants

Arm A: Mosun-Pola69.7 percentage of participants
Arm B: R-GemOx44.1 percentage of participants
p-value0.0008
Difference in Overall Response Rates25.68 (95% CI 9.60–41.76)

Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans

Up to 32 months · months

Arm A: Mosun-Pola11.5 months
Arm B: R-GemOx3.8 months
p-value<0.0001
Hazard Ratio (HR)0.41 (95% CI 0.28–0.61)

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