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 |
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| 相 | 第3相 |
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| スポンサー | Hoffmann-La Roche |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 208 名 |
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| 介入(薬剤) | Mosunetuzumab, Polatuzumab vedotin, Tocilizumab, Rituximab, Gemcitabine |
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| 開始日 | 2022年4月25日 |
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| 完了日 | 2025年2月17日 |
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| 結果公開日 | 2026年3月6日 |
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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-Pola | 69.7 percentage of participants |
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| Arm B: R-GemOx | 44.1 percentage of participants |
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| p-value | 0.0008 |
| Difference in Overall Response Rates | 25.68 (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-Pola | 11.5 months |
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| Arm B: R-GemOx | 3.8 months |
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| p-value | <0.0001 |
| Hazard Ratio (HR) | 0.41 (95% CI 0.28–0.61) |
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