EUCTR2016-001991-31-DE进行中（未招募）1 期
Phase IIIb study for relapsed/refractory pediatric/young adult acute lymphoblastic leukemia patients to be treated with CTL019. - Phase IIIb study for CTL019.
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
- 70
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 program have to meet all of the following criteria:
- •1. Relapsed or refractory B-cell ALL in pediatric or young adult patients
- •2. For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of study entry with adequate organ function.
- •3. Adequate organ function as defined in the protocol.
- •4. Bone marrow with = 5% lymphoblasts by morphologic assessment at Screening
- •5. Life expectancy > 12 weeks.
- •6. Age < 26 years of age at the time of Screening.
- •7. Karnofsky (age = 16 years) or Lansky (age < 16 years) performance status = 50 at Screening.
- •8. Patients previously treated with blinatumomab who have detectable leukemia and documented CD19+ expression (via flow cytometry) and confirmed absence of CD19- leukemic blasts at Screening may be included.
- •9. Signed written informed consent form (ICF) and assent form if applicable must be obtained prior to any study procedures
- •10. Must meet the institutional criteria to undergo leukapheresis or have an acceptable, stored leukapheresis product.
- •11. Once all other eligibility criteria are confirmed, must have a leukapheresis product of nonmobilized 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 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: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •1. Isolated extra-medullary disease relapse.
- •2. Patients 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.
- •3. Patients with Burkitt's lymphoma/leukemia.
- •4. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
- •5. Prior treatment with any gene therapy product.
- •6. Prior treatment with any anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy, except for patients pre-treated with linatumomab
- •who fulfill inclusion criterion no. 8.
- •7. Presence of active or prior hepatitis B or C as indicated by serology (for detailed criteria see Appendix 2 of main protocol). Serology must be repeated, if the interval between testing at Screening and CTL019 infusion exceeds 8 weeks.
- •8. HIV positivity as indicated by serology. Serology must be repeated, if the interval between testing at Screening and CTL019 infusion exceeds 8 weeks.
- •9. Presence of grade 2 to 4 acute or extensive chronic graft versus host disease (GVHD).
- •10. Active CNS involvement by malignancy.
- •11. Uncontrolled acute life threatening bacterial, viral or fungal infection at Screening.
- •12. Previous or concurrent malignancy (exceptions defined in the protocol)
- •13. Intolerance to the excipients of the CTL019 cell product (i.e. dimethyl sulfoxide).
- •14. Cardiac or cardiac repolarization abnormality.
- •15. Patients enrolled in this study are not permitted to participate in additional parallel investigational drug or device studies.
- •16. Patient has an investigational medicinal product within the last 30 days prior to screening.
- •17. The following medications are excluded:
- •a. Steroids,
- •b. Allogeneic cellular therapy,
- •c. GVHD therapies,
- •d. Chemotherapy,
- •e. CNS disease prophylaxis,
- •f. Radiotherapy,
- •g. Anti-T cell antibodies.
- •18. Pregnant or nursing (lactating) women.
- •19. Women of child-bearing potential
- •20. Sexually active males must use a condom during intercourse while taking study treatment and for at least 12 months after the CTL019
- •infusion and until CAR T cells are no longer present by qPCR on 2 consecutive tests.
- •Other protocol-defined exclusion criteria may apply.
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