EUCTR2016-001991-31-IT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
- 74
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
- •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:
- •a. Second or greater bone marrow relapse, OR
- •b. Any bone marrow relapse after allogeneic SCT and must be = 6
- •months from SCT at the time of CTL019 infusion, OR
- •c. Primary refractory as defined by not achieving a CR after 2 cycles of a
- •standard chemotherapy regimen or chemorefractory as defined by not
- •achieving a CR after 1 cycle of standard chemotherapy for relapsed
- •leukemia, OR
- •d. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible
- •if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor
- •(TKI) therapy, or if TKI therapy is contraindicated, OR
- •e. Ineligible for allogeneic SCT because of:
- •- Comorbid disease,
- •- Other contraindications to allogeneic SCT conditioning regimen,
- •- Lack of suitable donor,
- •- Prior SCT,
- •- Declines allogeneic SCT as a therapeutic option after documented
- •discussion about the role of SCT with a bone marrow transplantation
- •physician who is not a member of the CTL019 study team.
- •2. For relapsed patients, CD19 tumor expression demonstrated in bone
- •marrow or peripheral blood by flow cytometry within 3 months of study
- •entry. For relapsed or refractory patients previously treated with
- •blinatumomab, CD19 tumor expression must be demonstrated (via flow
- •cytometry) at Screening.
- •3. Adequate organ function defined as:
- •a. Renal function defined as: A serum creatinine based on age/gender as
- •follows: Maximum Serum Creatinine (mg/dL) - Age/Male/Female: 1 to <
- •2 years/0.6/0.6; 2 to < 6 years/0.8/0.8; 6 to < 10 years/1.0/1.0; 10 to
- •< 13 years/1.2/1.2; 13 to < 16 years/1.5/ 1.4; = 16 years/1.7/1.4.
- •b. Alanine Aminotransferase (ALT) = 5 times the upper limit of normal
- •(ULN) for age.
- •c. Bilirubin < 2.0 mg/dL.
- •d. Must have a minimum level of pulmonary reserve defined as = Grade 1
- •dyspnea and pulse oxygenation > 91% on room air.
- •e. Left Ventricular Shortening Fraction (LVSF) = 28% confirmed by
- •echocardiogram (ECHO), or Left Ventricular Ejection Fraction (LVEF) =
- •45% confirmed by echocardiogram or Multiple Uptake Gated Acquisition
- •(MUGA) within 7 days of screening.
- •4. Bone marrow with = 5% lymphoblasts by morphologic assessment at
- •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. In this case, at least 1-week washout period must be applied
- •from last dose of blinatumomab to start of leukapheresis. Patients
- •previously treated with blinatumomab with no detectable MRD (i.e. MRD
- 另有 8 项未显示
排除标准
- •1. Isolated extra-medullary disease relapse.
- •2. Patients with concomitant genetic syndromes.
- •3. Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation).
- •4. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
- •5. Treatment with any prior 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 blinatumomab
- •who fulfill inclusion criterion no. 8.
- •7. Presence of active replication of hepatitis B or hepatitis C (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.
- •10. Active CNS involvement by malignancy.
- •11. Uncontrolled acute life threatening bacterial, viral or fungal infection at Screening.
- •12. Previous or concurrent malignancy with the following exceptions:
- •a. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry).
- •b. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study.
- •c. A primary malignancy which has been completely resected and in CR for = 5 years.
- •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. Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
- •18. Pregnant or nursing (lactating) women.
- •19. Sexually active males must use a condom during intercourse from enrollment 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.
- •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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