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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 109
- 试验地点
- 38
- 主要终点
- Part 1: Complete remission (CR) within the first 3 treatment cycles
研究概览
简要总结
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Part 1: To evaluate the RP2D and RP2D-1 of MK-1045 (target dose) with respect to CR.
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Part 1: To evaluate the safety and tolerability of the RP2D and RP2D-1 of MK-1045.
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Part 2: To compare MK-1045 to blinatumomab with respect to CR.
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To compare MK-1045 to blinatumomab with respect to OS.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •≥12 years of age.
- •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.
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) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded.
- •History of serious cardiovascular and cerebrovascular diseases.
- •Has not adequately recovered from major surgery or have ongoing surgical complications.
研究组 & 干预措施
BLINATUMOMAB
干预措施: BLINATUMOMAB (Drug)
TOCILIZUMAB
干预措施: TOCILIZUMAB (Drug)
MK-1045
干预措施: MK-1045 (Drug)
结局指标
主要结局
Part 1: Complete remission (CR) within the first 3 treatment cycles
Part 1: Complete remission (CR) within the first 3 treatment cycles
Part 1: Number of participants with an adverse event (AE)
Part 1: Number of participants with an adverse event (AE)
Part 1: Number of participants discontinuing from study therapy due to AE
Part 1: Number of participants discontinuing from study therapy due to AE
Part 2: Percentage of participants with CR within the first 3 treatment cycles
Part 2: Percentage of participants with CR within the first 3 treatment cycles
Part 2: Overall survival (OS)
Part 2: Overall survival (OS)
次要结局
- Part 1: OS
- Part 1: Percentage of participants with minimal residual disease (MRD) negativity within the first 3 treatment cycles
- Part 1: Percentage of participants with CR, complete remission with partial hematologic recovery (CRh), or complete remission with incomplete count recovery (CRi) within the first 3 treatment cycles
- Part 2: Percentage of participants with MRD negativity within the first 3 treatment cycles
- Part 2: Percentage of participants with CR or CRh within the first 3 treatment cycles
- Part 2: Percentage of participants with CR, CRh, or CRi within the first 3 treatment cycles
- Part 2: Duration of CR
- Part 2: Duration of CR/CRh
- Part 2: Duration of CR, CRh, or CRi
- Part 2: Event free survival (EFS)
- Part 2: Percentage of participants who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Part 2: Percentage of participants who experienced an adverse event (AE)
- Part 2: Percentage of participants who discontinued study intervention due to an AE
研究者
Razia Bibi Akhtar
Scientific
Merck Sharp & Dohme LLC