EUCTR2016-002966-29-BE进行中（未招募）1 期
Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA) - BELINDA
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
- 354
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
- •1. Histologically confirmed, aggressive B-cell NHL at relapse/progression or PR after front line therapy. For patients with relapse/progression if biopsy after relapse/progression is not available or it is not clinically feasible to obtain a new biopsy, an archival tumor biopsy from the initial diagnosis may be submitted. For patients in PR after at least 6 cycles of first line treatment, a new biopsy must be submitted. Aggressive B-cell NHL is heretofore defined by the following list of subtypes:
- •a. DLBCL, NOS
- •b. FL grade 3B,
- •c. Primary mediastinal Large B cell lymphoma (PMBCL),
- •d. T cell rich/histiocyte rich large B cell lymphoma (T/HRBCL),
- •e. DLBCL associated with chronic inflammation,
- •f. Intravascular large B-cell lymphoma,
- •g. ALK+ large B-cell lymphoma,
- •h. B-cell lymphoma, unclassifiable, (with features intermediate between DLBCL and classical HL),
- •i. High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements,
- •j. High-grade B-cell lymphoma, NOS
- •k. HHV8+ DLBCL, NOS
- •l. DLBCL transforming from follicular lymphoma
- •m. DLBCL transforming from marginal zone lymphoma
- •n. DLBCL, leg type
- •2. 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).
- •3. Patient is considered eligible for autologous HSCT as per local investigator assessment.
- •4. Disease that is both active on PET scan and measurable on CT scan defined as:
- •a. Nodal lesions >15 mm in the long axis, regardless of the length of the short axis, and/or
- •b. Extranodal lesions (outside lymph node or nodal mass, but including liver and spleen) >10 mm in long AND short axis
- •5. ECOG performance status 0 or 1
- •6. Adequate organ function:
- •Renal function defined as:
- •-a Serum creatinine of =1.5 x ULN, OR eGFR = 60 mL/min/1.73 m2
- •Hepatic function defined as:
- •b- ALT and AST = 5 × ULN
- •c-Total Bilirubin =1.5 × 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:
- •d- Absolute neutrophil count (ANC) >1,000/mm3
- •e- Platelets =50,000/mm3
- •f- Hemoglobin >8.0 g/dl
- •Only for patients with non-historical apheresis:
- •g- Platelets =50,000/mm3
- •h- Hemoglobin >8.0 g/dl
- •Adequate pulmonary function defined as:
- •i- No or mild dyspnea (= Grade 1)
- •j- Oxygen saturation measured by pulse oximetry > 90% on room air
- •k- Forced expiratory volume in 1 s (FEV1) <50% or carbon monoxide diffusion test (DLCO) <50% of predicted level
- •7. Must have a leukapheresis material of non-mobilized cells available for manufacturing.
- •Other protocol-defined inclusion criteria may apply.
- •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 283
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 71
排除标准
- •1. Prior treatment with anti-CD19 therapy, adoptive T cell therapy or any prior gene therapy product
- •2. Treatment with any systemic lymphoma-directed second line anticancer therapy prior to randomization. Only steroids and local irradiation are permitted for disease control.
- •3. Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and local treatment was >4 weeks before randomization
- •4. Prior allogeneic HSCT
- •5. Uncontrolled acute life threatening infection
- •6. Any of the following cardiovascular conditions:
- •?- Unstable angina, myocardial infarction, coronary artery bypass graft (CABG), or stroke within 6 months prior to screening,
- •? -LVEF <45% as determined by ECHO or MRA or MUGA at the screening assessment.
- •? -NYHA functional class III or IV (Chavey et al 2001), at screening or within the past 12 months.
- •? - Clinically significant cardiac arrhythmias complete left bundle branch block, high-grade AV
- •block 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:
- •o Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome
- •o Concomitant medication(s) with a Known Risk of Torsades de Pointes” that cannot be discontinued or replaced by safe alternative medication.
- •7. Patients with active neurological autoimmune or inflammatory disorders and clinically significant active cerebrovascular disorders.
- •Other protocol-defined exclusion criteria may apply.
研究者
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