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

3상 진행 중(모집 완료) NCT05171647

대상 질환Non-Hodgkin Lymphoma
임상 단계3상
스폰서Hoffmann-La Roche
상태진행 중(모집 완료)
참여자 수208 명
중재(약물)Mosunetuzumab, Polatuzumab vedotin, Tocilizumab, Rituximab, Gemcitabine
시작일2022년 4월 25일
완료일2025년 2월 17일
결과 공개일2026년 3월 6일

요약

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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