NCT04679506Unknown不适用
Clinical Observation on the Efficacy and Safety of CLAE Regimen (Cladribine + Cytarabine + Etoposide) in the Treatment of Relapsed/Refractory T- Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- ORR
研究概览
简要总结
To evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL.
详细描述
This study is a prospective, open, multiple -centered, sing-arm trial. The major aim of this studies to evaluate the efficacy and safety of CLAE regimen (cladribine + cytarabine + etoposide) in the treatment of relapsed/refractory T-ALL/LBL. The study will include 50 subjects to receive CLAE regimen for reinduction chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 T-acute lymphoblastic leukemia/lymphoblastic lymphoma according to World Health Organization (WHO) criteria which has relapsed or is refractory to chemotherapy.
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •The expected survival period is more than 12 weeks.
- •At least one measurable nidus
- •Adequate organ function defined as:
- •Calculated creatinine clearance ≥ 50 ml/min using the cockcroft -Gault formula
- •AST, ALT, total bilirubin ≤ 2 x upper limit of normal (ULN) except for Gilbert's disease or when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia), in which case ALT and AST may be elevated up to ≤ 5 x ULN.
- •Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
排除标准
- •Previous treatment with nelarabine or clofarabine or fludarabine or cladribine was ineffective.
- •Pregnant or nursing.
- •Received any other investigational agent or systemic cytotoxic chemotherapy within the preceding 2 weeks.
- •Active HIV or hepatitis B or C infection.
- •Any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, laboratory tests, and according to the investigator's judgment.
结局指标
主要结局
ORR
时间窗: From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days)
Objective response rate，sum of complete response rate and partial response rate
次要结局
- PFS(From the date of first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- OS(From the date of first study drug administration until the date of death due to any cause, assessed up to 24 months.)
研究者
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