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: 20.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10063621Term: Acute lymphoblastic leukaemia recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
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
- 55
- 状态
- 进行中（未招募）
- 最后更新
- 5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:
- •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,
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.
结局指标
主要结局
未指定
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