NCT01948180终止2 期
A Phase 2 Single Arm Study to Investigate the Efficacy of Autologous EBV-specific T-cells for the Treatment of Patients With Aggressive EBV Positive Extranodal NK/T-cell Lymphoma (ENKTCL)
Cell Medica Ltd22 个研究点 分布在 4 个国家目标入组 15 人开始时间: 2014年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 22
- 主要终点
- Overall response rate
研究概览
简要总结
To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FOR SCREENING PHASE:
- •Inclusion Criteria:
- •Diagnosis of extranodal NK/T lymphoma, per WHO classification, 4th ed., which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1 immunostaining.
- •a) Active Disease
- •(1) Clinically suspected or documented relapse/progression, in first or second relapse following at least one cycle of an asparaginase-based chemotherapy regimen OR (2) Initial disease or first or second relapse and unable to tolerate one full cycle of asparaginase-based chemotherapy regimen OR b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotherapy.
- •Male or female ≥ 18 years of age.
- •Weigh ≥ 35 kg.
- •ECOG performance score 0-2, inclusively.
- •Negative β-hCG test in women of childbearing potential.
- •Able to understand and comply with the requirements of the study and to provide written informed consent.
排除标准
- •CNS lymphoma.
- •NK cell leukemia.
- •Hemophagocytic lymphohistiocytosis.
- •Positive for HIV, hepatitis B, hepatitis C, syphilis or human T Cell leukemia virus (HTLV).
- •Use of systemic corticosteroids >0.5 mg/kg/day within 10 days prior to obtaining 200 mL whole blood starting material.
- •Patient is pregnant or lactating.
- •Active second malignancy.
- •Any prior allogeneic hematopoietic stem cell or solid organ transplant.
- •Asparaginase refractory disease, defined by any one of the following:
- •Progression at any time during initial asparaginase based chemotherapy and up to 3 months after end of initial asparaginase based chemotherapy, OR
- •Failure to achieve at least PR with initial asparaginase based chemotherapy.
- •Absolute lymphocyte count (ALC) <400/µL.
- •Any previous autologous EBV specific T cell treatment.
- •Systemic fungal, bacterial, viral or other infection that is not controlled.
- •Third or greater relapse.
- •FOR TREATMENT PHASE:
- •Inclusion Criteria:
- •Documented relapse or progression following at least one prior cycle of an asparaginase-containing chemotherapy regimen.
- •Active disease based on any one of the following present at the baseline study visit or within two weeks prior to the baseline study visit:
- •Imaging (may use local imaging)
- •Clinical sign(s) including skin lesions consistent with lymphoma, organ dysfunction or organomegaly not attributable to other causes; or other clinical sign(s)
- •Detectable blood or plasma ENV DNA (may use local laboratory)
- •Completed most recent course of chemotherapy at least 2 weeks prior to first study drug dose.
- •Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities as defined by ≤ Grade 1 according to NCI CTCAE v4.
- •Life expectancy ≥ 8 weeks.
- •Exclusion Criteria:
- •Use of any investigational agents within prior 4 weeks.
- •Radiotherapy within prior 3 weeks.
- •Major surgery within prior 2 weeks.
- •Systemic corticosteroids within 24 hours prior to study drug administration.
- •Evidence of hepatic dysfunction based on serum total bilirubin >3 times upper limit of normal (ULN), or ALT >5 times ULN or AST >5 times ULN.
研究组 & 干预措施
baltaleucel-T
Experimental
Treatment consists of 2 infusions of 2x10E7 cells/m2 given on Days 1 and 15 intravenously via a peripheral or central line over a 1 to 10 minute period.
Subjects who tolerate the study treatment well and who do not require treatment with an alternative chemotherapeutic agent will be eligible for up to 3 additional infusions of 2x10E7 cells/m2 administered at week 8, month 3 and month 6.
干预措施: baltaleucel-T (Biological)
结局指标
主要结局
Overall response rate
时间窗: 1 year
Defined as best observed response (complete response or partial response) per Lugano 2014 Disease Response Criteria.
次要结局
- Complete Response Rate(1 year)
- Disease Free Survival(2 years)
- Response Duration(2 years)
- Progression Free Survival(2 years)
- Overall Survival(2 years)
- Adverse Events(1 year)
- Time to Response(1 year)
研究者
研究点 (22)
Loading locations...
相似试验
终止
2 期
Cellular Immunotherapy for Viral Induced Cancer - EBV Positive LymphomasLymphoma, Large B-Cell, DiffusePost-transplant Lymphoproliferative DisorderHodgkin LymphomaNCT02763254Cell Medica Ltd1
已完成
1 期
A Study of the Safety and Efficacy of EBV Specific T-cell LinesEpstein-Barr Virus InfectionsLymphomaPost-Transplant Lymphoproliferative DisorderNCT02580539Dr. Jean-Sebastien Delisle, MD, PhD12
已完成
1 期
Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B CellLymphoma, Non-HodgkinLymphoma, B-CellSmall Lymphocytic LymphomaChronic Lymphocytic LeukemiaNCT03019055Medical College of Wisconsin26
已完成
1 期
EBV-TCR-T Cells for EB Virus Infection After HSCTEBV Emia and EBV Positive PTLD After Allogenic HSCTNCT04156217Hebei Yanda Ludaopei Hospital18
已完成
2 期
Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCR and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant or Refractory Acute Lymphoblastic LeukemiaPatients With B Cell ALL, Relapsed or Refractory, With no Available Curative Treatment OptionsNCT02030847University of Pennsylvania42