jRCT2031260140尚未招募不适用
A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
未提供0 个研究点目标入组 21 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 性别
- All
入选标准
- •Has a confirmed diagnosis of relapsed/refractory (R/R) B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow.
- •Has CD19+ disease, confirmed by local flow cytometry and/or immunohistochemistry testing at the time of enrollment.
- •Has Philadelphia-negative disease, confirmed by testing, at the time of enrollment.
- •Participants who have AEs due to previous anticancer therapies must have recovered to Grade <=1 or baseline.
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
排除标准
- •Has Burkitt's leukemia.
- •History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic/ischemic stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis.
- •Has active acute graft versus host disease (GvHD), Grade 2 to 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment.
- •History of serious cardiovascular and cerebrovascular diseases.
- •HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- •Received prior treatment with blinatumomab within 12 weeks for Part 1 and 24 weeks for Part 2 before the first dose of study intervention (individuals known to be refractory or intolerant to blinatumomab are to be excluded).
- •Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- •Known additional malignancy that is progressing or has required active treatment within the past 2 years.
- •Isolated extramedullary disease (EMD).
- •Active autoimmune disease unrelated to ALL that has required systemic treatment in the past 2 years or history of autoimmune disease with potential CNS involvement.
- •Active infection requiring systemic therapy.
- •Has not adequately recovered from major surgery or have ongoing surgical complications.
研究者
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