NCT06378138招募中2 期
A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 226
- 试验地点
- 50
- 主要终点
- Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria
研究概览
简要总结
Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 80 years.
- •CLL/SLL is diagnosed by histopathology and/or flow cytometry according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2018):
- •Having an indication for treatment that meets the criteria for iwCLL 2018
- •Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.
- •Adequate hematologic function
- •Patients with basically normal coagulation function
- •Patients with adequate hepatic, renal, pulmonary and cardiac functions
- •Subjects are able to communicate with the investigator well and to complete the study as specified in the study.
- •Before the trial, the subjects shall understand the nature, significance, possible benefits, inconveniences and potential risks, as well as the study procedures of the trial in detail and voluntarily sign the written Informed Consent Form (ICF).
排除标准
- •Central nervous system involvement.
- •Concomitant Richter transformation.
- •Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.
- •Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.
- •History of allogeneic stem cell transplantation.
- •Major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational drug or require elective surgery during the trial.
- •Presence of active infection that requires intravenous anti-infective therapy.
- •Hepatitis B or C virus infection.
- •History of immunodeficiency disease or Significant cardiovascular disease
- •Central nervous system disorders or Severe bleeding disorder
- •Alcohol or drug dependence.
- •Mental disorders or poor compliance.
研究组 & 干预措施
ICP-248 in combination with Orelabrutinib
Experimental
干预措施: ICP-248 (Drug)
ICP-248 in combination with Orelabrutinib
Experimental
干预措施: Orelabrutinib (Drug)
结局指标
主要结局
Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria
时间窗: Up to 6 years
Changes from baseline in pulse.
时间窗: Up to 6 years
Changes from baseline in blood pressure.
时间窗: Up to 6 years
Changes from baseline in ECG QRS interval.
时间窗: Up to 6 years
Changes from baseline in ECG QT interval.
时间窗: Up to 6 years
次要结局
未报告次要终点
研究者
研究点 (50)
Loading locations...
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