EUCTR2018-002697-45-SE进行中（未招募）1 期
Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in PediatricPatients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia In First or Second Relapse - ISAKIDS
Sanofi-aventis recherche & developpement0 个研究点目标入组 128 人开始时间: 2018年12月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
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
- •- Participant must be 28 days to less than 18 years of age, at the time of signing the informed consent.
- •- Participants must have a confirmed diagnosis of relapsed Acute Lymphoblastic Leukemia (ALL) of T- or B-cell origin including T-lymphoblastic lymphoma (LBL), or relapsed Acute Myeloblastic Leukemia (AML) including participants with history of myelodysplasia.
- •- Participants must be previously treated for their disease and have relapsed or are refractory to most recent treatment. Participants in first or second relapse will be eligible regardless of the remission duration.
- •- Participants with no more than 1 prior salvage therapy.
- •- WBC counts below 20 x109/L on Day 1 before isatuximab administration.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 128
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any serious active disease or co-morbid condition which, in the opinion of the Investigator, may interfere with the safety of the study treatment or the compliance with the study protocol.
- •- Participants must have been off prior treatment with immunotherapy/investigational agents and chemotherapy for >2 weeks and must have recovered from acute toxicity before the first study treatment administration. Exceptions are participants who need to receive cytoreductive chemotherapy in order to decrease tumor burden (the study treatment may start earlier if necessitated by the patient's medical condition (eg, rapidly progressive disease) following discussion with the Sponsor).
- •- Prior stem cell transplant within 3 months and/or evidence of active systemic Graft versus Host Disease (GVHD) and/or immunosuppressive therapy for GVHD within 1 week before the first study treatment administration.
- •- Participants with LBL with bone marrow blasts <5%.
- •- Participants with Burkitt-type ALL.
- •- Acute leukemia with testicular or central nerve system involvement alone.
- •- Participants who have developed therapy related acute leukemia.
- •- Live vaccine(s) within 30 days prior to the first IMP administration or plans to receive such vaccines during the study until 90 days after the last IMP administration.
- •- Participants with white blood cell count > 50 x109/L at the time of screening visit.
- •- Participants who have been exposed to anti-CD38 therapies within 6 months prior to Day-1.
研究者
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2 期
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