NL-OMON54738招募中2 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) - CASSIOPEIA - CTL019G2201J
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 4
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
- 12 至 64（—）
入选标准
- •1. CD19 expressing (in peripheral blood or bone marrow by flow cytometry)
- •B-cell Acute
- •Lymphoblastic Leukemia
- •2. De novo NCI HR B-ALL who received first-line treatment and are MRD >= 0.01%
- •(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
- •and will be assessed by multi-parameter flow cytometry using central laboratory
- •3. Age 1 to 25 years at the time of screening
- •4. Lansky (age < 16 years) or Karnofsky (age >= 16 years) performance status >=
- •5. Adequate organ function during the screening period
- •6. Prior induction and consolidation chemotherapy allowed:
- •1st line subjects: <= 3 blocks of standard chemotherapy for first-line B-ALL,
- •4-drug induction, Berlin-Frankfurt-Münster (BFM) consolidation or phase 1b, and
- •interim maintenance with high-dose methotrexate. Protocols that are allowed
- •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
- •Additional (augmented) chemotherapy such as clofarabine and ifosfamide added
- •to induction/consolidation therapybprior to enrollment, leukapheresis and
- •infusion are not
- •allowed. Subject should be enrolled (leukapheresis accepted by Novartis
- •manufacturing)
- •on study before the initiation of the third dose planned dose of high-dose
- •methotrexate during interim maintenance therapy
- •8. Must meet the institutional criteria to undergo leukapheresis
- •9. Once all other eligibility criteria are confirmed, must have a leukapheresis
- •product of nonmobilized
- •cells received and accepted by the manufacturing site.
排除标准
- •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 or evidence of
- •progression in the peripheral blood or new extramedullary disease prior to
- •enrollment.Patients with previous CNS
- •disease are eligible if there is no active CNS involvement of leukemia (defined
- •as CNS-3 by NCCNv1 2018) at the time of screening.
- •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 subjects with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or
- •other known bone marrow failure syndrome. Subjects with Down syndrome will not
- •7. Subjects with Burkitt*s lymphoma/leukemia (i.e. subjects with mature B-ALL,
- •with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with
- •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. Clinically significant active infection confirmed by clinical evidence,
- •imaging, or positive
- •laboratory tests (e.g., blood cultures, PCR for DNA/RNA, etc.)
- •12. Presence of active hepatitis B or C (for detailed criteria
- •see Appendix 3).
- •13. Human Immunodeficiency Virus (HIV) positivity as indicated by serology.
- •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
- •first relapse following tisagenlecleucel infusion.
- •15. 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
- •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
- •b. Medications to be stopped at least 1 week prior to tisagenlecleucel infusion:
- •* 6-thioguanine, asparaginase (non-pegylated), vincristine, 6-mercaptopurine,
- •intrathecal methotrexate
- •c. Medications to be stopped at least 2 weeks prior to tisagenlecleucel
- •* Anthracyclines and cytarabine
- •* Intravenous methotrexate.
- •* Radiotherapy: Non-CNS site of radiation
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