EUCTR2018-001039-29-ES进行中（未招募）1 期
A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED, CONTROLLED STUDY INVESTIGATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH CHOP OR CHP-POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
入选标准
- •Phase Ib and Phase II
- •- Age >= 18 years
- •- At least one bi-dimensionally measurable nodal lesion
- •- Life expectancy of at least 24 weeks
- •- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- •- Left ventricular ejection fraction defined by multiple-gated acquisition scan or echocardiogram within the institutional limits of normal
- •- Adequate hematologic function
- •- Contraception use
- •- Histologically confirmed B-cell NHL according to WHO 2016 classification
- •- R/R B-cell NHL after at least one prior systemic lymphoma therapy
- •- Treatment with at least one prior CD20-directed therapy
- •- Group B only: no prior treatment with polatuzumab vedotin
- •- Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification
- •- International Prognostic Index score of 2-5
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •- Pregnant or breastfeeding, or intending to become pregnant during the study
- •- Prior treatment with mosunetuzumab and prior stem-cell transplant
- •- Contraindication to receive full dose of any of the individual components
- •- Current Grade >1 peripheral neuropathy
- •- Received systemic immunosuppressive medications
- •- Current or past history of central nervous system (CNS) lymphoma
- •- Current or past history of CNS disease
- •- Prior radiotherapy to the mediastinal/pericardial region
- •- History of other malignancy
- •- Recent major surgery
- •- Prior treatment with >250 mg/m2 doxorubicin (or equivalent anthracycline dose)
- •- Prior treatment with chemotherapy, immunotherapy, and biologic therapy within a specified period
- •- Prior treatment with radiotherapy within a specified period
- •- Adverse events from prior anti-cancer therapy resolved to <= Grade 1
- •- Patients with transformed lymphoma
- •- Prior therapy for B-cell NHL
研究者
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