NCT06583837招募中2 期
A Prospective, Multicenter, Phase II Study of Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of Local-stage Mucosa Associated Lymphoid Tissue Extranodal Marginal Zone Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1-year event-free survival (EFS)
研究概览
简要总结
Investigate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation in the treatment of local-stage MALT lymphoma
详细描述
This prospective, multicenter trial is trying to evaluate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation as first-line treatment of local-stage mucosa associated lymphoid tissue extranodal marginal zone lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Age ≥ 18 years old
- •Histologically confirmed mucosa-associated lymphoid tissue (MALT) lymphoma
- •Lugano stage I-II
- •Signed informed consent
- •Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109/L, PLT ≥ 50 × 109/L, Hb ≥ 80g/L; b) Liver function: bilirubin ≤1.5 times the upper limit of normal (ULN), ALT and AST<3 x ULN, serum albumin ≥ 30 g/L; c) Renal function: serum Cr<1.5 × ULN, creatinine clearance rate ≥ 50mL/min (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL/min); d) Coagulation function (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at the time of screening): International standardized ratio (INR) ≤ 1.5 x ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
排除标准
- •Recent major surgery (within 4 weeks prior to enrollment), except for diagnostic surgery
- •Have uncontrolled intercurrent diseases (cardiovascular and cerebrovascular diseases, coagulation disorders, severe infectious diseases) including but not limited to: severe acute or chronic infection requiring systemic treatment, symptomatic congestive heart failure (NYHA III-IV) or symptomatic or poorly controlled arrhythmias, arterial hypertension (systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥100mmHg) that is not controlled even with standard treatment, unstable angina, active peptic ulcer or bleeding disorder;
- •Severe concomitant diseases that interfere with treatment
- •Active interstitial pneumonia
- •Active chronic hepatitis B infection (defined as HBV DNA positive; patients with latent or prior hepatitis B infection (defined as positive for hepatitis B surface antigen or hepatitis B core total antibody) can be included if HBV-DNA is undetectable at screening. The above-mentioned patients must voluntarily undergo regular DNA tests and receive appropriate antiviral therapy as prescribed)
- •Positive hepatitis C test result (for patients who are positive for HCV antibodies, only polymerase chain reaction (PCR) shows a negative HCV RNA can participate)
- •Patients with active HIV and syphilis infections;
- •Pregnant or lactating women
- •Patients with multiple factors affecting oral medication (such as dysphagia, nausea, vomiting, chronic diarrhea, and intestinal obstruction)
- •The researcher determined that patients are not suitable to participate in this study.
研究组 & 干预措施
Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation
Experimental
Orelabrutinib was administrated for 12 weeks, followed by response-adapted ultra-low dose 4Gy radiation for local stage MALT EMZL
干预措施: Orelabrutinib (Drug)
Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation
Experimental
Orelabrutinib was administrated for 12 weeks, followed by response-adapted ultra-low dose 4Gy radiation for local stage MALT EMZL
干预措施: response-adapted radiation (Radiation)
结局指标
主要结局
1-year event-free survival (EFS)
时间窗: 1 year
the period from the date of patients sign informed consent to the observed event for any reason
次要结局
- 6-months CR rate(up to 6 months)
- 2-year event-free survival (EFS)(From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years)
- 2-year progression-free survival (PFS)(From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
- 2-year overall survival rate(From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Throughout the treatment period, up to 1 year)
- Quality of life questionnaire(EORTC QLQ-C30)(Up to 1 year)
研究者
Yizhen Liu
Clinical Professor
Fudan University
研究点 (1)
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