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

第3相 実施中(募集終了) NCT05171647

対象疾患Non-Hodgkin Lymphoma
第3相
スポンサーHoffmann-La Roche
ステータス実施中(募集終了)
参加者数208 名
介入(薬剤)Mosunetuzumab, Polatuzumab vedotin, Tocilizumab, Rituximab, Gemcitabine
開始日2022年4月25日
完了日2025年2月17日
結果公開日2026年3月6日

概要

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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