jRCT2011240023招募中不适用
A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 主要终点
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
- •Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations
- •Participants greater than 18 years are eligible
- •Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease
- •AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only
- •For Both Phase 1 and 2:
- •Pretreatment clinical laboratory values meeting the following criteria:
- •(a) Hematology: white blood cell (WBC) count less than or equal to (<=) 20*10^9/liter (L) and (b) renal function; Estimated or measured glomerular filtration rate greater than or equal to (>=) 50 milliliter per minute (mL/min) per four variable modified diet in renal disease (MDRD) equation
- •A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
- •Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment
排除标准
- •Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria
- •Active central nervous system (CNS) disease
- •Prior solid organ transplantation
- •QTc according to Fridericia's formula (QTcF) for males >= 450 millisecond (msec) or for females >= 470 msec. Participants with a family history of Long QT syndrome are excluded
- •Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant <=3 months before the first dose of study treatment; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion <=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses <=10 milligrams (mg) prednisone or equivalent are
- •allowed for adrenal replacement)
- •Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 halflives of the agent (whichever is shorter)
结局指标
主要结局
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
时间窗: Up to 4 years and 9 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with AEs by Severity
时间窗: Up to 4 years and 9 months
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Percentage of Participants with Dose-Limiting Toxicity (DLT)
时间窗: Up to 28 days Cycle 1
Percentage of participants with DLT will be assessed accordingly to national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 5.
Rate of Complete Remission or Complete Remission with Partial Hematologic Recovery (CR/CRh)
时间窗: Up to 4 years and 9 months
Rate of CR/CRh is defined as the percentage of participants achieving a CR or CRh at any time post-treatment.
次要结局
- Plasma Concentration of Bleximenib(Up to 4 years and 9 months)
- Overall Response Rate (ORR)(Up to 4 years and 9 months)
- Duration of Response (DOR)(Up to 4 years and 9 months)
- Time To Response (TTR)(Up to 4 years and 9 months)
- Duration of Complete Response (CR)/Complete Remission With Partial Hematologic Recovery (CRh)(Up to 4 years and 9 months)
- Time To CR/CRh(Up to 4 years and 9 months)
- Event-free survival (EFS)(Up to 4 years and 9 months)
- Overall survival (OS)(Up to 4 years and 9 months)
- Measurable Residual Disease (MRD) Negativity Among Participants Achieving CR/CRh/CRi(Up to 4 years and 9 months)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 4 years and 9 months)
- Number of Participants Reporting Transfusion Independence(Up to 4 years and 9 months)
研究者
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