NCT06255704尚未招募2 期
A Single-arm, Single-center, Open-label Phase II Study of Zanubrutnib Combined With R-CHOP/R-DHAP Alternating Regimen for First-line MCL and Followed by Zanubrutinib Rituximab Maintenance Therapy
Shanxi Province Cancer Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年3月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- CR rate after 6 cycles of induction therapy
研究概览
简要总结
Evaluation the efficacy and safety of Zanubrutinib + R-CHOP/R-DHAP for the treatment mantle cell lymphoma.
详细描述
A single-arm, single-center, open-label phase II study of Zanubrutinib combined with R-CHOP/R-DHAP alternating induction therapy followed by Zanubrutinib rituximab maintenance therapy.The primary objective of this study was to assess CR and ORR rates after 6 cycles of initiation (i.e., at the end of induction therapy), and to collect adverse events during induction and maintenance therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of MCL according to WHO classification;
- •Previously untreated MCL.
- •Age ≥ 18 and ≤ 70 years old.
- •ECOG, 0~
- •Suitable for high-dose treatment including high-dose Ara-C.
- •Stage II-IV (Ann Arbor).
- •Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI). Measurable disease was defined as at least 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions; in case of bone marrow infiltration only, bone marrow aspiration and biopsy are mandatory for all staging evaluations.
- •The following laboratory tests during the screening period (unless related to MCL disease)
- •Neutrophils ≥1×109/L within 7 days prior to study entry, and no growth factor support therapy.
- •Platelets ≥75×109/L within 7 days prior to study entry without growth factor support or blood transfusion.
- •Hemoglobin ≥75g/L shall not be transfused within 7 days before the test. If bone marrow is involved, neutrophils ≥0.75×109/L, platelets ≥50×109/L, hemoglobin ≥50g/L)
- •Creatinine clearance ≥30ml/min
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× upper limit of normal (ULN).
- •International Standardized ratio (INR) ≤1.5 and activated partial prothrombin kinase time (APTT) ≤1.5×ULN. If there is a clotting factor inhibitor that causes an elevated INR or prolonged APTT, it is up to the investigator to decide whether to enroll the patient.
- •Sexually active men and women of child-bearing potential must agree to use highly effective contraceptives (eg, condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 90 days after the last dose of study drug
- •Life expectancy > 3 months.
- •Written informed consent form according to GCP and national regulations.
排除标准
- •Known CNS involvement of MCL, Leukemic non-lymphonodular mantle cell lymphoma was excluded.
- •Major surgery within 4 weeks of screening
- •Concomitant or previous malignancies within the last 2 years other than basal cell skin cancer or in situ uterine cervix cancer
- •Clinically significant cardiovascular disease such as uncontrolled arrhythmias and hypertension , congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below 50%（AHA，2016）
- •QTcF > 450 msec or other significant electrocardiogram (ECG) abnormalities including second-degree atrioventricular block Type II, or third-degree atrioventricular block
- •Clinically significant hypersensitivity (eg, anaphylactic or anaphylactoid reactions to the compound of zanubrutinib itself or to the excipients in its formulation)
- •Requires treatment with strong CYP3A inhibitors or strong CYP3A inducers
- •Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
- •Active infection including infections requiring oral or intravenous antimicrobial therapy
- •Patients with unresolved hepatitis B or C infection or known HIV positive infection
- •History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
- •Pregnancy or lactation
- •Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could have compromised the patient's safety, or put the study at risk
- •Participation in another clinical trial within 30 days before enrollment in this study
- •poor compliance
研究组 & 干预措施
Zanubrutinib and RCHOP/RDHAP
Experimental
Patients will receive zanubrutinib and RCHOP alternating with RDHAP for a total of 6 cycles of induction therapy, and patients who achieve complete response after 6 cycles of induction therapy will be eligible to enter a 2-year maintenance treatment period of zanubrutinib in combination with rituximab
干预措施: Zanubrutinib and RCHOP/RDHAP (Drug)
结局指标
主要结局
CR rate after 6 cycles of induction therapy
时间窗: 18 weeks
To evaluate the CR rate after Zanubrutinib-based induction therapy in subjects with newly diagnosed MCL.
次要结局
- duration of response, DOR(60 weeks)
- Overall survival (OS)(60 weeks)
- ORR rate after 6 cycles of induction therapy(18 weeks)
- Progression free survival (PFS)(60 weeks)
- MRD negative rate at the end of induction therapy(18 weeks)
研究者
研究点 (1)
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