JPRN-jRCT1080224705已完成2 期
A Phase II, single arm, multicenter open label trial to determine the safety and efficacy of tisagenlecleucel in pediatric subjects with relapsed or refractory mature B-cell non-Hodgkin lymphoma (NHL) (BIANCA)
ovartis Pharma. K.K.0 个研究点目标入组 2 人开始时间: 2019年5月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 25age old（—）
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study must meet all of the following criteria:
- •-Histologically confirmed (local evaluation) mature B-cell non-Hodgkin lymphoma (B-cell NHL) including the following subtypes; Burkitt lymphoma/Burkitt leukemia (BL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), gray zone lymphoma (GZL), and follicular lymphoma (FL) Note: Patients with B-cell NHL associated with Nijmegen breakage syndrome will be allowed.
- •-Patients =<25 years of age and weighing at least 6 kg at the time of screening
- •-Patients who have relapsed after one or more prior therapies (can include allogeneic and autologous hematopoietic stem cell transplant) or are primary refractory (have not achieved a CR or PR after the first line of therapy)
- •-Measurable disease by radiological criteria in all patients at the time of screening.
- •-Karnofsky (age >=16 years) or Lansky (age <16 years) performance status >=60.
- •-Adequate bone marrow reserve without transfusions (transfusion >2 weeks prior to laboratory assessment is allowed) defined as:
- •a. Absolute neutrophil count (ANC) >1000/mm3
- •b. Platelets >=50000/mm3
- •c. Hemoglobin >=8.0 g/dl
- •-Adequate organ function:
- •a. a serum creatinine (sCR) based on gender/age as follows:
- •Maximum Serum Creatinine (mg/dL)
- •Age: 1 to <2 years; Male: 0.6, Female: 0.6
- •Age: 2 to <6 years; Male: 0.8, Female: 0.8
- •Age: 6 to <10 years; Male:1.0, Female:1.0
- •Age:10 to <13 years; Male: 1.2, Female:1.2
- •Age:13 to <16 years; Male: 1.5, Female:1.4
- •Age: >=16 years; Male: 1.7, Female: 1.4
- •b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =<5 times the upper limit of normal (ULN) for age
- •c. Total bilirubin <2 mg/dL (for Gilbert Syndrome patients total bilirubin <4 mg/dL)
- •d. Adequate pulmonary function
- •i. Oxygen saturation of >91% on room air
- •ii. No or mild dyspnea (=9. Must have a leukapheresis material of non-mobilized cells accepted for manufacturing.
排除标准
- •Patients meeting any of the following criteria are not eligible for inclusion in this study.
- •-Prior gene therapy or engineered T cell therapy
- •-Prior treatment with any anti-CD19 therapy
- •-Allogeneic hematopoietic stem cell transplant (HSCT) <3 months prior to screening and =<4 months prior to infusion
- •-Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD) in patients who received prior allogeneic HSCT.
- •-Prior diagnosis of malignancy other than study indication, and not disease free for 5 years
- •-Clinically significant active infection confirmed by clinical evidence, imaging, or positive laboratory tests
- •-Presence of active hepatitis B or C as indicated by serology.
- •-Human Immunodeficiency Virus (HIV) positive test.
- •-Active neurological autoimmune or inflammatory disorders not related to B cell NHL (eg: Guillain-Barre syndrome, Amyotrophic Lateral Sclerosis)
- •-Active central nervous system (CNS) involvement by malignancy.
- •-Patients with B-cell NHL in the context of post-transplant lymphoproliferative disorders (PTLD) associated lymphomas
- •-Patients with concomitant genetic syndromes associated with bone marrow failure status such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome.
- •-Cardiac disorder defined as:
- •a. Cardiac or cardiac repolarization abnormality, including any of the following:
- •i. History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to starting study treatment
- •ii. Clinically significant cardiac arrhythmias (eg: ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (eg: bifascicular block, Mobitz type II and third degree AV block)
- •b. Left ventricular ejection fraction (LVEF) <45% as determined by echocardiography (ECHO) or magnetic resonance angiogram (MRA) or multigated acquisition (MUGA)
- •c. New York Heart Association (NYHA) functional class III or IV (Chavey et al 2001)
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