EUCTR2019-002930-35-DE进行中（未招募）1 期
Phase II trial of TisaGenlecleucel in Elderly Patients with First-Relapsed or Primary Refractory Agressive B-cell Non-Hodgkin Lymphoma - TIGER-CTL019
niveristy of Cologne0 个研究点目标入组 28 人开始时间: 2020年8月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
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. Written, signed and dated informed consent
- •2. Patients with first relapse of aggressive B-cell Non-Hodgkin’s Lymphoma (aNHL) within 365 days after rituximab- and anthracycline-containing first-line immunochemotherapy or aNHL refractory to respective 1st-line therapy (no achievement of a CR or PR) who are ineligible for either autologous or allogeneic stem cell transplantation, defined as age > 65 years, or > 60 years old with HCT-CI score >2 and not older than 80 years
- •3. Histologically confirmed aNHL as defined by a list of subtypes
- •4. Measurable disease:
- •Nodal lesions >15 mm in the long axis, regardless of the length of the short axis,
- •Extranodal lesions (outside lymph node or nodal mass, but including liver and spleen) >10 mm in long AND short axis
- •5. ECOG performance status 0-2
- •6. Adequate organ function:
- •o Serum creatinine of =1.5 x ULN, or estimated glomerular filtration rate (GFR) = 30mL/min/1.73m2
- •o Hepatic function defined as:
- •? ALT and AST = 5 × ULN, except for aNHL-related functional impairment.
- •? Bilirubin = 2.0 mg/dL except for patients with Gilbert syndrome who may be included if their total bilirubin is = 3.0 × ULN and direct bilirubin = 1.5 × ULN OR for aNHL-related functional impairment
- •o Adequate bone marrow function
- •o Minimum level of pulmonary function
- •7. Life expectancy of more than six months
- •8. Women have to be in menopausal or post-menopausal status or confirmed as not having potential on childbearing. Male participants with female partners of childbearing potential are eligible to participate if they agree to contraceptive methods
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1. Patients with Richter’s transformation, Burkitt lymphoma, and PCNSL
- •2. Prior treatment with anti-CD19 therapy, adoptive T cell therapy, or any prior gene therapy product
- •3. Treatment with any lymphoma-directed second line anticancer therapy prior to enrollment with the exception of intermittent steroid therapy. After enrollment, bridging therapy is permitted for disease control
- •4. Patients with active CNS involvement
- •5. Prior autologous or allogeneic stem cell transplantation (HSCT)
- •6. Active hepatitis B, hepatitis C, or hepatitis E infection
- •7. HIV-positive patients
- •8. Uncontrolled acute life-threatening bacterial, viral or fungal infection (e.g. blood culture positive = 72 hours prior to infusion)
- •9. Cardiac dysfunction
- •10. Previous or concurrent malignancy with the exceptions
- •11. Women of childbearing potential (WOCBP), pregnant or lactating women
- •12. Intolerance to the excipients of the tisagenlecleucel cell product
- •13. Active or history of inflammatory disorders or autoimmune disease that required systemic steroids or immunosuppressive medications, with exception of vitiligo or resolved childhood asthma
- •14. Active tuberculosis
- •15. Exposure to any investigational agent(s) within 4 weeks prior to study entry
- •16. Chemotherapy less than 2 weeks before leukapheresis
- •17. Simultaneous radiotherapy to tisagenlecleucel infusion (radiotherapy between leukapheresis and day -6 before tisagenlecleucel infusion is permitted)
- •18. Ongoing necessity for systemic corticosteroids >10mg daily prednisone equivalent. Inhaled or topical steroids and adrenal replacement steroid doses > 10mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
- •19. History of active primary immunodeficiency
- •20. Major surgery (defined as opening at least one body cavity) within 4 weeks prior to study entry
- •21. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening CT scan
- •22. Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibodies, other immune checkpoint inhibitors
- •23. Prior treatment with any anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
- •24. Current treatment within another therapeutic clinical trial with experimental and not approved drugs and treatment combinations
- •25. Patient’s lack of accountability and inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
- •26. Non-compliance
- •27. Patients who have a relationship of dependence or employer-employee relationship to the sponsor or the investigator
- •28. Committal to an institution on judicial or official order
研究者
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