EUCTR2017-002116-14-IT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 - Study of efficacy and safety of tisagenlecleucel in HR B-ALL EOC MRD positive patients.
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
- 140
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
入选标准
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •1. CD19 expressing B-cell Acute Lymphoblastic Leukemia
- •2. De novo NCI HR B-ALL who received 1st line treatment and are at MRD = 0.01% at EOC. EOC bone marrow MRD will be collected prior to screening and will be assessed by multi-parameter flow cytometry using central laboratory analysis.
- •3. Age 1 to 25 years at the time of screening
- •4. Lansky (age <16 years) or Karnofsky (age =16 years) performance status =60% at screening
- •5. Adequate organ function during the screening period
- •Renal function based on age/gender as described in the protocol
- •ALT =5 times ULN for age
- •AST =5 times ULN for age
- •Total bilirubin <2 mg/dL (for Gilbert’s Syndrome patients 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 within 6 weeks of screening
- •6. Prior induction and consolidation chemotherapy allowed, as decribed in the protocol
- •7. Signed written informed consent and assent forms, if applicable, must be obtained prior to any study procedures
- •8. Must meet the institutional criteria to undergo leukapheresis
- •9. 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 confirmation of all other clinical eligibility criteria is received.
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 125
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients eligible for this study must not meet any of the following criteria:
- •1. M3 marrow (= 25% blasts by morphologic criteria) at the completion of first-line induction therapy
- •2. M2 (i.e. = 5% blasts by morphologic criteria) or M3 marrow or persistent extramedullary disease at the completion of first-line consolidation therapy. Patients with previous CNS disease are eligible if there is no active CNS involvement of leukemia at the time of enrollment.
- •3. Philadelphia chromosome positive (Ph+) ALL
- •4. Hypodiploid: less than 44 chromosomes and/or DNA index < 0.81, or other clear evidence of a hypodiploid clone
- •5. Prior tyrosine kinase inhibitor therapy
- •6. Subjects with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.
- •7. Patients with Burkitt’s lymphoma/leukemia (i.e. patients with mature B-ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation).
- •8. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
- •9. Has had treatment with any prior anti-CD19 therapy
- •10. Treatment with any prior gene or engineered T cell therapy
- •11. Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive = 72 hours prior to tisagenlecleucel infusion)
- •12. Presence of active or prior hepatitis B or C as indicated by serology. Serology must be repeated, if the interval between testing at screening and tisagenlecleucel infusion exceeds 8 weeks.
- •13. Human Immunodeficiency Virus (HIV) positivity as indicated by serology. Serology must be repeated, if the interval between testing at screening and tisagenlecleucel infusion exceeds 8 weeks.
- •14. 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 CTL019 infusion.
- •15. If subjects are taking any of the medications defined in the protocol, their infusion (including a second infusion) must be delayed until the medications have been stopped (details according to in the protocol):
- •a. Medications to be stopped > 72 hours prior to tisagenlecleucel infusion: Therapeutic systemic doses of steroids.
- •b. Medications to be stopped at least 1 week prior to tisagenlecleucel infusion:
- •6-thioguanine, asparginase (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 infus
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