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Paediatric/young adult patients with B-cell acute lymphoblastic leukaemia who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic SCT.MedDRA version: 20.0 Level: LLT Classification code 10063625 Term: Acute lymphoblastic leukemia recurrent System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10063621 Term: Acute lymphoblastic leukaemia recurrent System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
相关药物Kymriah
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Paediatric/young adult patients with B-cell acute lymphoblastic leukaemia who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic SCT.
- 发起方
- ovartis Pharma AG
- 入组人数
- 70
- 状态
- 进行中（未招募）
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
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
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.
结局指标
主要结局
未指定
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