EUCTR2018-002442-37-NL进行中（未招募）1 期
A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab in combination with other anti-cancer therapies in participants with lymphoma
Sanofi-aventis recherche & developpement0 个研究点目标入组 145 人开始时间: 2018年12月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 145
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Participants must be = 12 years of age inclusive, at the time of signing the informed consent
- •- Disease location amenable to tumor biopsy at baseline
- •- Measurable disease
- •- For Cohort A1 (classic Hodgkin's lymphoma [cHL] anti-programmed cell death protein 1/ligand 1 [PD-1/PD-L1] inhibitor naïve): Histologically confirmed advanced cHL that has relapsed or progressed after at least 3 lines of systemic therapy that may include autologous hematopoietic stem cell transplant (auto-HSCT) or auto-HSCT and brentuximab vedontin (BV)
- •-Cohort A2: classic Hodgkin’s lymphoma with documentation of benefit but subsequent progression during or after the prior anti-PD1/PD-L1 containing regimen. Progression has to occur within 6 months from last dose of the prior anti-PD1/PD-L1 containing regimen
- •- For Cohort B (diffuse large B-cell lymphoma [DLBCL]):Histologically confirmed advanced DLBCL that has relapsed or progressed after 2 lines of systemic therapy including auto-HSCT or 2 lines of systemic therapy for participants who are not eligible for auto-HSCT
- •- For Cohort C (peripheral T-cell lymphoma [PTCL]): Histologically confirmed advanced PTCL that has relapsed or progressed after either first-line chemotherapy and auto-HSCT as consolidation of first remission or first-line chemotherapy if participants are ineligible for auto-HSCT
- •- Body weight of > 45 kg for patients with age <18 years
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •-Prior exposure to agent that blocks CD38
- •- For patients with cHL (PD-1/PD-L1 naïve), DLBCL or PTCL prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1, PD-L2, CD137, CTLA-4 or LAG-3
- •- Evidence of other immune related disease /conditions
- •- Has received a live-virus vaccination within 28 days of planned treatment start; seasonal flu vaccines that do not contain live virus are permitted
- •- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =2
- •- Poor bone marrow reserve
- •- Poor organ function
研究者
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