An Open, Prospective, Single-arm Study of Olverembatinib Plus Venetoclax and Dexamethasone in Patients of Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete molecular remissions (CMR) rates
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL.
详细描述
PRIMARY OBJECTIVES:
To determine the Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates, the measurable residual disease (MRD) rates, the complete molecular remissions (CMR) rates and the progression-free survival (PFS) of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL.
SECONDARY OBJECTIVES:
To describe the toxicities of the OVD regimen. To assess the quality of life and overall survival of the OVD chemotherapy-free regimen in patients with newly-diagnosed Ph+ALL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of newly-diagnosed Ph+ acute lymphoblastic leukemia
- •Age >= 18
- •Adequate hepatic function
- •Adequate renal function
- •Adequate heart function
- •Life expectancy of more than 3 months
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity from the time of signing the informed consent for through 120 days after the last dose of study medication.
- •Women of childbearing potential have negative pregnancy test within 72 hours of initiating study drug dosing.
- •Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- •All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- •Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program.
排除标准
- •Current or anticipated use of other investigational agents.
- •Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- •Major surgery within 3 weeks prior to first dose
- •Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
- •Known or suspected HIV infection, known HIV seropositivity
- •Active hepatitis infection
- •Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal
- •Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance, including difficulty swallowing
研究组 & 干预措施
OVD regimen of Olverembatinib plus venetoclax and dexamethasone
Olverembatinib: orally every other day at a dose of 40mg Venetoclax: in a daily ramp-up strategy (100 mg d4, 200 mg d5, 400 mg d6-17) Dexamethasone: intravenously 10mg, d1-14, 5mg, d15-28
干预措施: Olverembatinib plus venetoclax and dexamethasone (Drug)
结局指标
主要结局
Complete molecular remissions (CMR) rates
时间窗: Three years
Progression-free survival (PFS)
时间窗: Three years
Negative measurable residual disease (MRD) rates
时间窗: Three years
Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates
时间窗: Three years
次要结局
未报告次要终点