EUCTR2020-003452-32-IT进行中（未招募）1 期
Phase I/II study of anti-CD19 Chimeric Antigen Receptor-Expressing T cells in pediatric patients affected by relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PML) - CD19-CAR_Lenti
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA0 个研究点目标入组 32 人开始时间: 2021年5月24日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
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
- •Procurement eligibility
- •1. Diagnosis of CD19 expressing B acute lymphoblastic leukemia (ALL) or diffuse large B-cell lymphoma (DLBCL) or primary mediastinal lymphoma (PML) and one of the following:
- •a. Patients in 1st relapse, with High-Risk (HR) features including: MLL-rearrangements, E2A/TCF3-PBX1 [t(1;19)], TCF3-HLF [t(17;19)], hypodiploidy (i.e., <44 chromosomes), TP53 alterations, early (i.e., <30 months from diagnosis)/very early (i.e.,
- •<18 months from diagnosis) isolated or combined bone marrow relapse
- •b. MRD > 0.1% after either reinduction therapy or any course of consolidation for relapsed ALL
- •c. Patients with DLBCL or PML in 1st or subsequent relapse, after at least one standard frontline chemotherapy
- •2. Age: 1 year – 25 years for BCP-ALL and 1-35 years for B-NHL.
- •3. Adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis
- •4. Voluntary informed consent is given. For subjects < 18 year-old their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate.
- •5. Clinical performance status: Patients > 16 years of age: Karnofsky greater than or equal to 60%; Patients < 16 years of age: Lansky scale greater than or equal to 60%.
- •Treatment eligibility (i.e., eligibility to drug product infusion)
- •1. Diagnosis of CD19 expressing B-ALL or DLBCL or PML and one of the following:
- •a. Patients in 1st relapse, with High-Risk (HR) features including: MLL-rearrangements, E2A/TCF3-PBX1, TCF3-HLF [t(17;19)], hypodiploidy (i.e., <44 chromosomes), TP53 alterations, early (i.e., <30 months from diagnosis)/very early (i.e., <18 months from diagnosis) isolated or combined bone marrow relapse
- •b. MRD > 0.1% after either reinduction therapy or any course of consolidation for relapsed
- •c. Patients with DLBCL or PML in 1st or subsequent relapse, after at least one standard frontline chemotherapy
- •2. Age: 1 year – 25 years for Bcp-ALL and 1-35 years for B-NHL.
- •3. Voluntary informed consent is given. For subjects < 18 year-old their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate.
- •4. Clinical performance status: Patients > 16 years of age: Karnofsky greater than or equal to 60%; Patients < 16 years of age: Lansky scale greater than or equal to 60%.
- •5. Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen.
- •6. Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.
- •Are the trial subjects under 18? yes
- •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 3
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Procurement eligibility
- •1. Severe, uncontrolled active infections
- •2. HIV, or active HCV and/or HBV infection (detection of viral RNA/DNA in blood)
- •3. Previous allogeneic HSCT in the preceding 100 days before apheresis
- •4. Concurrent or recent prior therapies, before apheresis:
- •a) Systemic steroids (at a dose equivalent to or greater 2 mg/kg prednisone) in the 2 weeks before apheresis collection. Recent or current use of inhaled/topical/non-absorbable steroids is not exclusionary.
- •b) Systemic chemotherapy in the 2 weeks preceding apheresis collection.
- •c) Anti-thymocyte globulin (ATG) in the 4 weeks preceding apheresis collection.
- •d) Immunosuppressive agents in the 2 weeks preceding apheresis collection.
- •e) Radiation therapy must have been completed at least 1 week prior to apheresis.
- •f) Other anti-neoplastic investigational agents currently administered or within 30 days prior to apheresis (i.e., start of protocol therapy);
- •Treatment eligibility
- •1. Pregnant or lactating women
- •2. Severe, uncontrolled active infections
- •3. HIV, or active HCV and/or HBV infection (detection of viral RNA/DNA in blood)
- •4. Life-expectancy < 6 weeks
- •5. Hepatic function: Inadequate liver function defined as total bilirubin > 4x upper limit of normal (ULN) or transaminase (ALT and AST) > 6 x ULN
- •6. Renal function: serum creatinine > 3x ULN for age.
- •7. Blood oxygen saturation < 90%.
- •8. Cardiac function: Left ventricular ejection fraction lower than 45% by ECHO.
- •9. Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject.
- •10. BM blasts > 50% pre-infusion.
- •11. Hyperleukocytosis (greater than or equal to 20,000 blasts/microliter) or rapidly progressive disease that in the evaluation of the investigator would compromise ability to complete study therapy
- •12. Presence of active, grade 2-4 acute or moderate-severe chronic GvHD
- •13. Recurrent or refractory ALL with testicular involvement
- •14. Concurrent or recent prior therapies, before infusion:
- •a) Systemic steroids (at a dose > 2 mg/kg prednisone) in the 2 weeks before infusion. Recent or current use of inhaled/topical/non-absorbable steroids is not exclusionary.
- •b) Systemic chemotherapy in the week preceding infusion.
- •c) Anti-thymocyte globulin (ATG) in the 4 weeks preceding infusion.
- •d) Immunosuppressive agents in the 1 week preceding infusion.
- •e) Radiation therapy must have been completed at least 3 weeks prior to enrollment.
- •f) Other anti-neoplastic investigational agents currently administered or within 30 days prior to infusion (i.e. start of protocol therapy);
- •15. Patient-derived CD19-CAR_Lenti production failure: vitality of the fresh product <80%, CD3+ cells <80%, CD3+ CAR+ cells <10%, non-sterility in IPC at day 5, endotoxin contamination (> 5 EU/ml) in IPC at day 5, mycoplasma contamination in IPC at day 5, failure of the visual inspection.
研究者
相似试验
进行中（未招募）
1 期
CD19-CART01 in pediatric patients affected by relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Non Hodgkin LymphomaAcute Lymphoblastic Leukemia and Non Hodgkin LymphomaMedDRA version: 20.0Level: HLGTClassification code 10018849Term: Haematological disorders NECSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2017-002088-16-ITBambino Gesù Children's Hospital32
招募中
1 期
Safety of Immune Cells for Patients with Relapsed Leukaemia or Lymphoma after Bone Marrow TransplantACTRN12617001579381Western Sydney Local Health District, Westmead Hospital20
尚未招募
1 期
Safety of Immune Cells for Patients with Relapsed Leukaemia or Lymphoma after ChemotherapyAcute Lymphoblastic LeukaemiaChronic Lymphocytic LeukaemiaNon-Hodgkins LymphomaCancer - Leukaemia - Acute leukaemiaCancer - Leukaemia - Chronic leukaemiaCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaACTRN12619000079145Western Sydney Local Health District, Westmead Hospital20
尚未招募
不适用
A pilot study of AT101 in anti-CD19 CAR T therapy-exposed patients with relapsed or refractory diffuse large B cell lymphomaNeoplasmsKCT0009570Asan Medical Center10
Unknown
1 期
Anti-CD19 CAR in PiggyBac Transposon-Engineered T Cells for Relapsed/Refractory B-cell Lymphoma or B-cell Acute Lymphoblastic LeukemiaB Cell LymphomaB-cell Acute Lymphoblastic LeukemiaNCT04289220Yan'an Affiliated Hospital of Kunming Medical University10