Venetoclax Combined With HAG Regimen in Treating Adult Relapse/Refractory Acute T Cell Lymphoblastic Leukemia/Lymphoma: A Phase II, Single Arm and Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Complete remission with or without incomplete PB cell recovery(CR/CRi) rate
研究概览
简要总结
Acute T cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) is an aggressive type of leukemia that results from the malignant evolution of T-lineage progenitor cells at different differentiation stages. After induction chemotherapy and consolidation chemotherapy, there are still about 30% of patients who cannot achieve complete remission of clinical symptoms or negative MRD. This is also an important factor for the recurrence of ALL patients. In addition, most relapsed T-ALL/LBL patients relapse during first-line treatment. Once the disease relapses, it is difficult to cure for most young and adult patients, and the overall survival rate of patients is less than 10%.
详细描述
This is a prospective, single-arm, phase II and open-label study. A total of 50 R/R T-ALL/LBL participants will be enrolled. The primary endpoint is complete remission with or without peripheral blood cell recovery. The induction therapy is a combination of Venetoclax(Ven), Homoharringtonine(HHT) , Cytarabine and G-CSF. The purpose of this study is to explore efficacy of the VHAG in the treatment of R/R T-ALL/LBL patients.
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
- 14 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before enrollment, a diagnosis of newly diagnosed T-cell acute leukemia/lymphoma.The diagnostic criteria refer to the 2022 WHO classification;
- •Age ≥ 14 years,<75 years;
- •Clincally diagnosed as relapsed or refractory T-ALL/LBL;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- •Expected survival time ≥ 2 months;
- •No organ dysfunction that would restrict the use of this protocol during the screening period;
- •Understand the study and sign the informed consent form.
排除标准
- •Patients with known central nervous system (CNS) involvement of T-ALL/LBL;
- •Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.)
- •Cardiac ultrasound LVEF < 45%;
- •History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
- •Serum total bilirubin > 1.5 ULN (upper limit of normal); ALT or AST > 2.5 ULN; serum creatinine > 1.5 ULN;
- •Known HIV infection;
- •Conditions affecting the use of the study drug as assessed by the investigator;
- •Inability to understand or comply with the study protocol.
研究组 & 干预措施
Treatment arm
Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.
干预措施: Venetoclax (Drug)
Treatment arm
Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.
干预措施: homoharringtonine (Drug)
Treatment arm
Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.
干预措施: Cytarabine (Ara-C) (Drug)
Treatment arm
Venetoclax for 4weeks(adjust according to BM on Day15), oral; Homoharringtonine for 1 week,iv; Cytarabine for 10-14 dsys, sc; G-CSF.
干预措施: G-CSF (Drug)
结局指标
主要结局
Complete remission with or without incomplete PB cell recovery(CR/CRi) rate
时间窗: at the end of Cycle 1 and 2（each cycle is 28days）
Blast rate lower than 5% with or without peripheral blood cell recovery
次要结局
- Overall survival (OS)(up to 5 years)
- Event free survival(EFS)(up to 2 years)
- Minimal residual disease (MRD)(At the end of Cycle 1 and 2（each cycle is 28 days）)
- Adverse event(At the end of Cycle 1 and 2)