NCT07548255尚未招募1 期
A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax and Zanubrutinib Combined With Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined with Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Histologically confirmed, previously untreated mantle cell lymphoma (MCL), with at least one of the following high-risk features:
- •Blastoid or pleomorphic morphology;
- •Ki-67 ≥30%;
- •TP53 mutation or deletion;
- •17p deletion;
- •High-risk MIPI group with an expected survival >3 months.
- •Laboratory criteria meeting the following requirements:
- •Absolute neutrophil count ≥1,000/mm³ or ≥1.0 × 10⁹/L, platelet count ≥50,000/mm³ or ≥50 × 10⁹/L, and hemoglobin ≥8 g/dL;
- •Creatinine clearance ≥50 mL/min (calculated using the standard Cockcroft-Gault formula);
- •Serum albumin ≥3.0 g/dL; total bilirubin ≤1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, or ≤5.0 × ULN in cases of hepatic lymphoma involvement; serum amylase or lipase ≤ULN;
- •International normalized ratio (INR) ≤1.5 × ULN or activated partial thromboplastin time (aPTT) ≤1.5 × ULN; for patients receiving warfarin anticoagulation therapy, INR may be between 2 and 3;
- •Cardiac function: left ventricular ejection fraction (LVEF) ≥50%.
排除标准
- •Contraindications to any of the study drugs.
- •Known history of clinically significant liver disease, including viral or other hepatitis or cirrhosis (hepatitis B defined as positive hepatitis B core antibody [HBcAb] with HBV-DNA above the ULN; active hepatitis C defined as positive HCV antibody-patients with negative HCV-RNA may be enrolled).
- •Human immunodeficiency virus (HIV) infection.
- •Congestive heart failure (New York Heart Association [NYHA] Class >2); history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment.
- •Congenital long QT syndrome or QTc >480 ms (QTc must be calculated using Fridericia's formula: QTcF = QT/(RR)^0.33).
- •History of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, carcinoma in situ of the breast, or other second primary malignancies that were curatively treated and have had no recurrence within 5 years.
- •Pregnant or breastfeeding women, or those planning to become pregnant during the study period (fertile men and women must agree to use effective contraception during the study and for 30 days after the last dose of study treatment, such as dual-barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. Postmenopausal women and surgically sterilized women are exempt).
- •Prior history of significant neurological or psychiatric disorders, or history of psychotropic drug abuse or substance abuse.
- •Clinically significant active infection.
- •Inability to take oral medications, difficulty swallowing, chronic diarrhea, intestinal obstruction, or other conditions that may affect drug administration or absorption.
研究组 & 干预措施
Sonrotoclax, Zanubrutinib Combined with Obinutuzumab treatment
Experimental
干预措施: Sonrotoclax, Zanubrutinib Combined with Obinutuzumab (Drug)
结局指标
主要结局
Complete response rate
时间窗: At the end of Cycle 6 (each cycle is 28 days)
The percentage of participants with a complete response at the end of Cycle 6 was determined on the basis of investigator assessments according to the Lugano Classification for Response Criteria in Lymphoma
次要结局
- Overall survival(2 years after enrollment)
- Overall response rate(Overall Response Rate At the end of Cycle 6 (each cycle is 28 days))
- Progression free survival(2 years after enrollment)
- Treatment-Related Adverse Events(From enrollment to study completion, a maximum of 3 years.)
研究者
研究点 (1)
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