NL-OMON55833已完成2 期
Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination with Chemotherapy in Pediatric Patients 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. - ACT15378 Isakids
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
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 ALL of T or B cell
- •origin including LBL, or relapsed AML (excluding M3 type: acute promyelocytic
- •leukemia) including participants with history of myelodysplasia (MDS).
- •- 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 x 109/L on Day 1 before isatuximab administration.
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 orde to decrease tumor burden. 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 x 109/L at the time of the
- •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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