jRCT1080223858已完成2 期
A Phase 2 Multicenter, Open-label, Single-arm Study of KTE-C19 in Japanese Patients with Refractory or Relapsed Large B Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- - Non-randomized - Open-label - Single-arm - No Control Group
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •A subject who satisfies all the criteria below will be enrolled in the study.
- •Histologically confirmed aggressive B-cell NHL (including the following types defined by the WHO 2016)
- •a) DLBCL, NOS
- •Germinal center B-cell lymphoma
- •Activated B-cell lymphoma
- •b) Intravascular large B-cell lymphoma
- •c) T-cell/histiocyte-rich large B-cell lymphoma
- •d) DLBCL associated with chronic inflammation
- •e) Epstein-Barr virus (EBV)positive diffuse large B-cell lymphoma, NOS
- •iv) High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement
- •v) High-grade B-cell lymphoma, NOS
- •Chemotherapy-refractory disease, defined as one or more of the following:
- •i) No response to first-line therapy (primary refractory disease); subjects who are intolerant to first-line therapy chemotherapy are excluded
- •a) Progressive Disease (PD) as best response to first-line therapy
- •b) Stable Disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP) with SD duration no longer than 6 months from last dose of therapy
- •ii) No response to second or greater lines of therapy
- •a) PD as best response to most recent therapy regimen
- •b) SD as best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy
- •iii) Relapsed post-ASCT
- •a) Disease progression or relapsed =< 12 months of ASCT (must have biopsy proven relapse in relapsed subjects)
- •b) if salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy (must have biopsy proven recurrence in relapsed subjects)
- •Subjects must have received at least the following therapy:
- •i) Anti-CD20 monoclonal antibody (unless the investigator or subinvestigator determines that tumor is CD20 negative)
- •ii) An anthracycline containing chemotherapy regimen;
- •iii) Prior chemotherapy for follicular lymphoma for subjects with transformed TFL (subsequently have a chemorefractory disease after transformation to DLBCL)
- •At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
排除标准
- •A patient who meets any of the following criteria is not eligible.
- •History of malignancy within the past 3 years (patients with skin cancer [except for melanoma] or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma are eligible even with a history within 3 years)
- •History of Richter's transformation of CLL
- •Autologous stem cell transplant within 6 weeks of planned KTE-C19 infusion
- •History of allogeneic stem cell transplant
- •Prior CD19 targeted therapy (except for subjects who are eligible for re-treatment of KTE-C19 in this study)
- •Prior CAR T cell therapy or other genetically modified T cell therapy (except for subjects who are eligible for re-treatment of KTE-C19 in this study)
结局指标
主要结局
ORR
percentage of patients judged CR or PR assessed by the investigator or subinvestigator based on the criteria of the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (Cheson 2007)
次要结局
- ORR
研究者
研究点 (1)
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