NCT06051409招募中3 期
A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Imatinib Combined With Chemotherapy in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 14
- 主要终点
- Minimal residual disease negativity rate
研究概览
简要总结
A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.
详细描述
Comparing efficacy and safety of Olverembatinib in combination with chemotherapy (investigational arm) vs. Imatinib in combination with chemotherapy (control arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Meet the WHO 2016 Ph chromosome or BCR/ABL1 positive Ph+ALL diagnostic and typing criteria for acute lymphoblastic leukemia. This is a newly diagnosed Ph+ALL.
- •Expected survival of at least 3 months.
- •Adequate organ function.
- •Use effective contraception during treatment and for at least three months after the last dose of the study drug, and male patients may not donate sperm.
- •Pregnancy test results of serum samples obtained within 7 days prior to the first dosing of a fertile female subject were negative.
- •Understand and voluntarily sign the informed consent approved by the Ethics Committee (EC) and voluntarily complete the study procedure and follow-up examination.
排除标准
- •A history of chronic myeloid leukemia and a diagnosis of acute leukemia with chronic myeloid leukemia.
- •Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly.
- •Previous or current clinical CNS diseases.
- •Autoimmune diseases that may involve the CNS.
- •Use therapeutic doses of anticoagulants and/or antiplatelet agents but allow low doses of anticoagulants to keep central venous lines open.
- •Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days prior to the first receipt of the investigational drug.
- •Uncontrolled Heart diseases.
- •Had any VTE in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism.
- •Use of prohibited drugs.
- •The presence of any disease or medical condition that is unstable or may affect its safety or compliance with the study.
- •Medications known to cause prolonged QT interval.
- •Active infections requiring systemic treatment.
- •Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer.
- •Contraindications to the use of glucocorticoids, and the researchers judge that they are not suitable to participate in this study.
- •Bleeding disorders unrelated to the tumor.
- •Plan to undergone major surgery.
- •Allergy to drug ingredients, excipients, or their analogues in the study.
- •Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study plan or within 3 months of the last dosing.
- •Other malignant tumors within 2 years.
- •Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study.
研究组 & 干预措施
Olverembatinib
Experimental
Olverembatinib in combination with chemotherapy
干预措施: Olverembatinib (Drug)
Imatinib
Active Comparator
Imatinib in combination with chemotherapy
干预措施: Imatinib (Drug)
结局指标
主要结局
Minimal residual disease negativity rate
时间窗: Cycles 1 to cycle 3 (each cycle is 28 days)
The minimal residual disease negativity rate of olverembatinib combined chemotherapy versus imatinib combined chemotherapy in subjects with newly diagnosed Ph+ALL.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.(Through study completion,an average of 2 years.)
- Plasma concentrations of olverembatinib(Cycle 1 to Cycle 3 (each cycle is 28 days))
- The patients' score of EORTC(The European Organization for Research and Treatment of Cancer) QLQ-C30.(Through study completion,an average of 2 years.)
研究者
研究点 (14)
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