EUCTR2017-004148-39-FR进行中（未招募）1 期
An open-label, first-in-human, dose escalation study of SAR440234 administered as single agent by intravenous infusion in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), or high risk myelodysplasia (HR-MDS)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 77
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
- •- Confirmed diagnosis of Acute Myeloblastic leukemia (AML) (except acute promyelocytic leukemia), or myelodysplastic syndrome (MDS) with a risk category of intermediate or higher.
- •- Patients with AML must be unlikely to benefit from cytotoxic chemotherapy.
- •- Patients with B-ALL (B acute lymphoid leukemia) in second or subsequent relapse.
- •- Patients with HR-MDS (high risk myelodysplastic syndrome) must have received =1 cycle of hypomethylating therapy or induction therapy and have =10% bone marrow blasts.
- •- Signed written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Age <16 years old.
- •- Eastern Cooperative Oncology Group (ECOG) performance status >2.
- •- Patients with inadequate biological tests.
- •- Graft-versus-host disease following allogeneic stem cell transplantation requiring treatment with more than 10 mg of oral prednisone or equivalent daily. The stem cell transplant and/or donor lymphocyte infusion should have been performed more than 3 months before study treatment start.
- •- Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
- •- Previous treatment with radiotherapy or immunotherapeutic agents in the 4 weeks prior to IMP administration
- •- Previous treatment with any other investigational agent in the 4 weeks prior to IMP administration
- •- Receiving, at the time of first IMP administration, of concurrent steroids >10 mg/day of oral prednisone or the equivalent for =3 months
- •- Requirement for tociluzimab for any other diagnosis.
- •- Evidence of active central nervous system leukemia at the time of enrollment.
- •- Acquired immunodeficiency syndrome (AIDS-related illnesses) or HIV disease requiring antiretroviral treatment.
- •- Active hepatitis B viral infection or hepatitis C viral infection; HIV infection.
- •- Women of childbearing potential, male with a partner of childbearing potential who do not agree to use effective methods of birth control.
- •- Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the patient or may interfere with compliance or interpretation of the study results.
研究者
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