這是一項隨機、開放標籤、多中心第三期試驗，比較 tisagenlecleucel 與標準治療在含 rituximab 及 anthracycline 第一線免疫化療失敗後的侵襲性 B 細胞非何傑金氏淋巴瘤成年患者中的療效、安全性及耐受性。
適應症：Non-Hodgkin Lymphoma
收案條件
納入條件
- Histologically confirmed, aggressive B-cell NHL at relapse/progression or PR after front line therapy. Aggressive B-cell NHL is heretofore defined by the following list of subtypes (Swerdlow et al 2016):
- DLBCL, NOS,
- FL grade 3B,
- Primary mediastinal large B cell lymphoma (PMBCL),
- T cell rich/histiocyte rich large B cell lymphoma (T/HRBCL),
- DLBCL associated with chronic inflammation,
- Intravascular large B-cell lymphoma,
- ALK+ large B-cell lymphoma,
- B-cell lymphoma, unclassifiable, (with features intermediate between DLBCL and classical Hodgkin's Lymphoma (HL)),
- High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements,
- High-grade B-cell lymphoma, NOS
- HHV8+ DLBCL, NOS
- DLBCL transforming from follicular lymphoma
- DLBCL transforming from marginal zone lymphoma
- DLBCL, leg type
- Relapse or progression within 365 days from last dose of anti CD20 antibody and anthracycline containing first line immunochemotherapy or refractory (have not achieved a CR).
- Patient is considered eligible for autologous HSCT as per local investigator assessment. Note: Intention to transplant and type of high dose chemotherapy (HDCT) regimen will be documented at the time of study entry
- Disease that is both active on PET scan (defined as 5-Deauville scorepoint-scale of 4 or 5) and measurable on CT scan, defined as::
- Nodal lesions \>15 mm in the long axis, regardless of the length of the short axis, and/or
- Extranodal lesions (outside lymph node or nodal mass, but including liver and spleen) \>10 mm in long AND short axis
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function:
- Renal function defined as:
- Serum creatinine of ≤1.5 x upper limit of normal (ULN), OR estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2
- Hepatic function defined as:
- Alanine Transaminase (ALT) and Aspartate Transiminase (AST) ≤ 5 × ULN
- Total bilirubin ≤ 1.5 x ULN with the exception of patients with Gilbert syndrome who may be included if their total bilirubin is ≤3.0 × ULN and direct bilirubin ≤1.5 × ULN
- Hematologic Function (regardless of transfusions) defined as:
- Absolute neutrophil count (ANC) \>1000/mm3
- Absolute lymphocyte count (ALC) \>300/mm3 OR Absolute number of CD3+ T cells \>150/mm3 (only for patients with non-historical apheresis)
排除條件
- Prior treatment with anti-CD19 therapy, T cell therapy, or any prior gene therapy product
- Treatment with any systemic lymphoma-directed second line anticancer therapy prior to randomization. Only steroids and local irradiation are permitted for disease control
- Patients with active central nervous system (CNS) involvement by disease under study are excluded, except if the CNS involvement has been effectively treated and local treatment was \>4 weeks before randomization
- Prior allogeneic HSCT
- Clinically significant active infection
- Any of the following cardiovascular conditions:
- Unstable angina, myocardial infarction, coronary artery bypass graft (CABG), or stroke within 6 months prior to screening,
- Left ventricle ejection fraction (LVEF) \<45% as determined by echocardiogram (ECHO) or magnetic resonance angiography (MRA) or multigated acquisition (MUGA) at the screening assessment.
- New York Heart Association (NYHA) functional class III or IV (Chavey et al 2001), within the past 12 months.
- Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II) and third degree AV block unless adequately controlled by pacemaker implantation.
- Resting QTcF ≥450 msec (male) or ≥460 msec (female) at screening or inability to determine the QTcF interval
- Risk factors for Torsades de Pointes (TdP), including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/ symptomatic bradycardia, or any of the following:
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome
- Concomitant medication(s) with a "Known Risk of Torsades de Pointes" per crediblemeds.org that cannot be discontinued or replaced by safe alternative medication.
- Patients with active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré Syndrome (GBS), Amyotrophic Lateral Sclerosis (ALS)) and clinically significant active cerebrovascular disorders (e.g. cerebral edema, posterior reversible encephalopathy syndrome (PRES))
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。