CTIS2023-508081-15-00进行中（未招募）1 期
A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy - CCTL019G2201J
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •CD19 expressing (in peripheral blood or bone marrow by flow cytometry) B-cell Acute Lymphoblastic Leukemia, De novo NCI HR B-ALL who received first-line treatment and are MRD = 0.01% at EOC (HR defined by NCI criteria at the time of initial leukemia presentation as age = 10 and/or WBC = 50 x 109 cells/L). EOC bone marrow MRD will be collected prior to screening and will be assessed by multi-parameter flow cytometry using central laboratory analysis, Age 1 to 25 years at the time of screening, Lansky (age < 16 years) or Karnofsky (age = 16 years) performance status = 60% at screening, Adequate organ function during the screening phase: •Renal function based on age/gender as follows: Age; 1 to < 2 years, Maximum Serum Creatinine =0.6(mg/dL) Age; 2 to < 6 years, Maximum Serum Creatinine =0.8(mg/dL) Age; 6 to < 10 years, Maximum Serum Creatinine =1.0(mg/dL) Age; 10 to < 13 years, Maximum Serum Creatinine =1.2(mg/dL) Age; 13 to < 16 years, Maximum Serum Creatinine =1.5(mg/dL) for male or 1.4(mg/dL) for female Age; = 16 years, Maximum Serum Creatinine =1.7(mg/dL) for male or 1.4(mg/dL) for female •Adequate liver function defined as: •ALT = 5 times ULN for age •AST = 5 times ULN for age •Total bilirubin < 2 mg/dL (for Gilbert’s Syndrome subjects total bilirubin < 4 mg/dL) •Adequate pulmonary function defined as: •no or mild dyspnea (= Grade 1) •oxygen saturation of > 90% on room air •Adequate cardiac function defined as LVSF = 28% confirmed by echocardiogram or LVEF = 45% confirmed by echocardiogram or MUGA during screening or within 6 weeks prior to screening, Prior induction and consolidation chemotherapy allowed: •1st line subjects: = 3 blocks of standard chemotherapy for first-line B-ALL, defined as 4-drug induction, Berlin-Frankfurt-Münster (BFM) consolidation or Phase 1b, and interim maintenance with high-dose methotrexate. Protocols that are allowed include the following: COG AALL0232 ([NCT00075725]), AALL1131 ([NCT02883049]) standard arm, COG AALL1732, European ALLTogether 1st line trial, Dana Farber Cancer Institute (DFCI) 16-001 (High Risk), Dutch Childhood Oncology Group (DCOG) ALL-11, European Organization for Research and Treatment of Cancer–Children’s Leukemia Group (EORTC-CLG) 58081 (variant 1), UKALL2011, or other comparable protocols if approved by Novartis (See Appendix 4 for approved regimens). •Additional (augmented) chemotherapy such as clofarabine and ifosfamide added to induction/consolidation therapy prior to enrollment, leukapheresis, or infusion are not allowed •Subject should be enrolled (leukapheresis accepted by Novartis manufacturing) on study before the initiation of the third dose of high-dose methotrexate during interim maintenance therapy, Signed written informed consent and assent forms, if applicable, must be obtained prior to any study procedures, Must meet the institutional criteria to undergo leukapheresis, Once all other eligibility criteria are confirmed, must have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site. NOTE: Leukapheresis product will not be shipped to or assessed for acceptance by the manufacturing site until documented IRT confirmation of all other clinical eligibility criteria is received.
排除标准
- •M3 marrow (= 25% blasts by morphologic criteria) at the completion of first-line induction therapy, Treatment with any prior gene or engineered T cell therapy, Clinically significant active infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA, etc.), Presence of active hepatitis B or C (for detailed criteria see Appendix 3), Human Immunodeficiency Virus (HIV) positivity as indicated by serology, Subject had an investigational medicinal product within the last 30 days prior to screening NOTE: Investigational therapies must not be used at any time while on study until the first relapse following tisagenlecleucel infusion, If subjects are taking any of the following medications, their infusion (including a second infusion) must be delayed until the medications have been stopped according to the following: a.Medications to be stopped > 72 hours prior to tisagenlecleucel infusion: •Therapeutic systemic doses of steroids. However, the following physiological replacement doses of steroids are allowed: < 12 mg/m2/day hydrocortisone or equivalent b.Medications to be stopped at least 1 week prior to tisagenlecleucel infusion: •6-thioguanine, asparaginase (non-pegylated), vincristine, 6-mercaptopurine, and intrathecal methotrexate c.Medications to be stopped at least 2 weeks prior to tisagenlecleucel infusion: •Anthracyclines and cytarabine •Intravenous methotrexate. •Radiotherapy: Non-CNS site of radiation d.Medications to be stopped at least 4 weeks prior to tisagenlecleucel infusion: •Pegylated-asparaginase e.Medications/Therapy to be stopped at least 8 weeks prior to tisagenlecleucel infusion: •Radiotherapy: Cranial radiation (for CNS 3 subjects) therapy, Pregnant or nursing (lactating) women. NOTE: Women of child-bearing potential must have a negative serum pregnancy test performed within 24 hours before leukapheresis, lymphodepletion and prior to tisagenlecleucel infusion, Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to use highly effective methods of contraception from enrollment through at least 12 months after the tisagenlecleucel infusion and until CAR-T cells are no longer present by qPCR on two consecutive tests. qPCR test results will be available upon request. Highly effective contraception methods include: •Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception •Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment •Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject •Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of ora
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