計劃書編號MK-1026-011
NCT Number(ClinicalTrials.gov Identfier)NCT06136559
試驗執行中
2023-10-15 - 2033-12-31
Phase III
尚未開始2
召募中2
一項第3期、隨機分配試驗，針對未接受治療之慢性淋巴性白血病／小淋巴球性淋巴瘤的受試者，比較Nemtabrutinib與對照藥物（試驗主持人選擇使用Ibrutinib或Acalabrutinib）（BELLWAVE-011）
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試驗申請者
美商默沙東藥廠股份有限公司台灣分公司
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試驗委託 / 贊助單位名稱
美商默沙東藥廠股份有限公司台灣分公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 尚未開始
適應症
慢性淋巴性白血病 /小淋巴球性淋巴瘤
試驗目的
主要目的
•由盲性獨立中央審查（BICR）根據2018年國際慢性淋巴球性白血病工作小組（iwCLL）標準進行評估，比較nemtabrutinib與ibrutinib或acalabrutinib的客觀反應率（ORR）。
•由BICR根據2018年iwCLL標準進行評估，比較nemtabrutinib與ibrutinib或acalabrutinib的PFS。
次要目的
•比較nemtabrutinib與ibrutinib或acalabrutinib的整體存活期（OS）。
•由BICR根據2018年iwCLL標準評估反應持續時間（DOR）。
•評估nemtabrutinib的安全性和耐受性。
藥品名稱
錠劑
錠劑
錠劑
主成份
MK-1026
MK-1026
MK-1026
劑型
Tablet
Tablet
Tablet
劑量
5 mg
20 mg
20 mg
評估指標
- OR：完全反應（CR）、完全反應而骨髓未完全恢復（CRi）、淋巴結部分反應（nPR）或部分反應（PR）。
- PFS：從隨機分配至首次記錄疾病惡化或任何原因而死亡的時間，以先發生者為準。
- PFS：從隨機分配至首次記錄疾病惡化或任何原因而死亡的時間，以先發生者為準。
主要納入條件
主要的納入條件包括但不限於以下：
•確診患有慢性淋巴性白血病／小淋巴球性淋巴瘤（CLL／SLL），且為明確記錄需要開始治療的活動性疾病。
•具有至少1項疾病負荷標記。
•隨機分配之前7天內的美國東岸癌症臨床研究合作組織（ECOG）體能狀態分數為0到2。
•有吞嚥和保留口服藥物的能力。
•B型肝炎表面抗原（HBsAg）陽性的受試者，如果已接受B型肝炎病毒（HBV）抗病毒療法至少4週且在隨機分配前檢測不到HBV去氧核糖核酸（DNA）病毒量，則符合資格。
•有C型肝炎病毒（HCV）感染病史的受試者，若篩選時無法測得HCV核糖核酸（RNA）病毒量，則符合受試資格。
•患有人類免疫缺乏病毒（HIV）的受試者，若符合所有條件，即具備納入資格。
•確診患有慢性淋巴性白血病／小淋巴球性淋巴瘤（CLL／SLL），且為明確記錄需要開始治療的活動性疾病。
•具有至少1項疾病負荷標記。
•隨機分配之前7天內的美國東岸癌症臨床研究合作組織（ECOG）體能狀態分數為0到2。
•有吞嚥和保留口服藥物的能力。
•B型肝炎表面抗原（HBsAg）陽性的受試者，如果已接受B型肝炎病毒（HBV）抗病毒療法至少4週且在隨機分配前檢測不到HBV去氧核糖核酸（DNA）病毒量，則符合資格。
•有C型肝炎病毒（HCV）感染病史的受試者，若篩選時無法測得HCV核糖核酸（RNA）病毒量，則符合受試資格。
•患有人類免疫缺乏病毒（HIV）的受試者，若符合所有條件，即具備納入資格。
主要排除條件
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
Has gastrointestinal (GI) dysfunction that may affect drug absorption.
Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
Has clinically significant cardiovascular disease.
Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
Has history of severe bleeding disorder.
Has history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
Has received any systemic anticancer therapy for CLL/SLL.
Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
Has active infection requiring systemic therapy.
Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
The main exclusion criteria include but are not limited to the following:
Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
Has gastrointestinal (GI) dysfunction that may affect drug absorption.
Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
Has clinically significant cardiovascular disease.
Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
Has history of severe bleeding disorder.
Has history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
Has received any systemic anticancer therapy for CLL/SLL.
Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
Has active infection requiring systemic therapy.
Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
試驗計畫預計收納受試者人數
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台灣人數
28 人
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全球人數
1200 人
