EUCTR2016-001991-31-BE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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
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 screening.
- •5. Life expectancy > 12 weeks.
- •6. Age 3 years at the time of screening to age 21 years at the time of initial diagnosis.
- •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 negative demonstrated by leukemic blasts < 0.01%) will be excluded.
- •Note: blinatumomab must not be administered as a bridging therapy prior to CTL019 infusion while the patient is awaiting manufacture of CTL019
- •9. Signed written informed consent and assent forms 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
排除标准
- •Exclusion Criteria:
- •1. Isolated extra-medullary disease relapse.
- •2. Patients with concomitant genetic syndrome
- •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. Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening.
- •8. Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening.
- •9. Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease.
- •10. Active CNS involvement by malignancy, defined as CNS-3 per NCCN guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible.
- •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 arrhythmia not controlled with medical management.
- •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.
- •18. 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
- •19. Women of child-bearing potential and all male participants, unless they are using effective methods of contraception for a period of 1 year after the CTL019 infusion.
- •- Sexually active women must continue to use contraception for greater than 12 months after the CTL019 infusion and until CAR T cells are no longer present by quantitative PCR (q-PCR) on 2 consecutive tests.
- •- Sexually active males must use a condom during intercourse for 12 months after CTL019 infusion and until CAR T cells are no longer present by q-PCR on 2 consecutive tests, as they should not father a child in this period. A condom is required to be used also by vasectomized men (as well as during intercourse with a male partner) as white blood cells (WBCs) are a normal part of semen and transmission of CTL019 transduced cells may occur.
- •Effective contraception methods include:
- •a. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient.
- •b. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone,
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