2024-512537-33-00已完成3 期
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination with Rituximab Plus Gemcitabine Plus Oxaliplatin (R- GEMOX) Versus R- GEMOX Alone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 19
- 主要终点
- 1. Incidence, nature and severity of physical findings and AEs, with a specific focus on peripheral neuropathy, according to the NCI CTCAE v5.0 (Stage 1)
研究概览
简要总结
To evaluate the efficacy of Pola-R-GemOx compared with R-GemOx alone on basis of the overall survival (OS) (Stage 2) To evaluate the safety and tolerability of Polatuzumab Vedotin (Pola)-R-GemOx as a combination therapy on basis of incidence, nature and severity of physical findings and adverse events (AEs), with a specific focus on peripheral neuropathy (PN), according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0) (Stage 1)
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase III, open-label, randomized, Polivy+ R-GEMOX vs R-GEMOX alone, diffuse large B-cell lymphoma
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically-confirmed DLBCL, not otherwise specified or history of transformation of indolent disease to DLBCL
- •Relapsed or refractory disease
- •At least one (>= 1) line of prior systemic therapy
- •At least one bi-dimensionally measurable lesion
- •Eastern Cooperative Oncology Group performance status of 0, 1 or 2
- •Adequate hematological function
排除标准
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- •Contraindication to rituximab, gemcitabine or oxaliplatin
- •Peripheral neuropathy assessed to be > Grade 1 according to NCI CTCAE v5.0 at enrollment
- •Prior use of polatuzumab vedotin or a gemcitabine + platinum-based agent combination
- •Enrollment in any previous or ongoing polatuzumab vedotin trial
- •Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
结局指标
主要结局
1. Incidence, nature and severity of physical findings and AEs, with a specific focus on peripheral neuropathy, according to the NCI CTCAE v5.0 (Stage 1)
1. Incidence, nature and severity of physical findings and AEs, with a specific focus on peripheral neuropathy, according to the NCI CTCAE v5.0 (Stage 1)
2. Overall survival (Stage 2)
2. Overall survival (Stage 2)
次要结局
- 11. OS (Stage 1)
- 1. Incidence and assessment of peripheral neuropathy, as measured by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-Item Scale (FACT-/GOG-NTX-12) (Stage 1)
- 2. Incidence, nature and severity of AEs (including peripheral neuropathy) according to NCI CTCAE v5.0 and physical findings (Stage 2)
- 3. Tolerability, as measured by dose interruptions, dose reductions and dose intensity (Stage 1 and 2)
- 4. Prevalence of ADAs to polatuzumab vedotin at baseline and incidence of ADAs during the study (Stage 1 and 2)
- 5. CR as determined by an independent review committee (IRC) (Stage 2)
- 6. CR as determined by investigator (Stage 1 and 2)
- 7. ORR as determined by an IRC (Stage 2)
- 8. ORR as determined by investigator (Stage 1 and 2)
- 9. BOR as determined by investigator (Stage 1 and 2)
- 10. PFS as determined by investigator (Stage 1 and 2)
- 12. Event-free survival (EFSeff ) as determined by investigator (Stage 1 and 2)
- 13. DOR as determined by investigator (Stage 2)
- 14. Time to deterioration in physical functioning and fatigue as measured by the European Organisation for the Research and Treatment of Cancer Quality-of-Life Questionnaire, Core 30 (Stage 2)
- 15. Time to progression in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy-Lymphoma subscale (Stage 2)
- 16. Change from baseline in peripheral neuropathy as measured by the FACT/GOG-NTX-12 subscale score (Stage 2)
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (19)
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