計劃書編號M20-638
NCT Number(ClinicalTrials.gov Identfier)NCT05409066
試驗執行中
2022-10-01 - 2030-05-31
Phase III
召募中5
一項第3期、開放性臨床試驗，目的在評估復發或難治性濾泡性淋巴瘤受試者使用Epcoritamab合併Rituximab和Lenalidomide (R2)治療相較於R2治療之安全性和療效(EPCORE? FL-1)
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試驗申請者
瑞士商艾伯維藥品有限公司台灣分公司
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試驗委託 / 贊助單位名稱
瑞士商艾伯維藥品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 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
復發或難治性濾泡性淋巴瘤
試驗目的
此隨機第3期臨床試驗目的在評估R/R FL受試者使用epcoritamab 合併R2治療相較於R2單獨治療之療效、安全性和耐受性。
主要療效試驗指標為無惡化存活期(PFS)：定義為自隨機分組日期至獨立審查委員會(IRC)以Lugano標準評估為疾病惡化或死亡(以先發生者為準)日期的時間。
藥品名稱
N/A
主成份
Epcoritamab
劑型
N/A
劑量
NA
評估指標
無惡化存活期(PFS)：定義為自隨機分組日期至獨立審查委員會(IRC)以Lugano 標準評估為疾病惡化或死亡(以先發生者為準)日期的時間。
主要納入條件
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
- Participant has:
Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible
with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
＞= 1 measurable nodal lesion (long axis ＞= 1.5 cm and short axis ＞ 1.0 cm) or ＞= 1 measurable extra-nodal lesion (long axis ＞= 1.0 cm) on CT scan or MRI.
- Histologically confirmed Grade 1 to 3a follicular lymphoma (FL) according to the World Health Organization (WHO) 2016 classification with no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy and CD20+ on a representative tumor biopsy based on the pathology report.
- Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with (an)other anti-lymphoma agent(s).
- Eligible to receive R2 per investigator determination.- Documented refractoriness to lenalidomide.
- Have lenalidomide exposure within 12 months prior to randomization.
- Participant has:
Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible
with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
＞= 1 measurable nodal lesion (long axis ＞= 1.5 cm and short axis ＞ 1.0 cm) or ＞= 1 measurable extra-nodal lesion (long axis ＞= 1.0 cm) on CT scan or MRI.
- Histologically confirmed Grade 1 to 3a follicular lymphoma (FL) according to the World Health Organization (WHO) 2016 classification with no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy and CD20+ on a representative tumor biopsy based on the pathology report.
- Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with (an)other anti-lymphoma agent(s).
- Eligible to receive R2 per investigator determination.- Documented refractoriness to lenalidomide.
- Have lenalidomide exposure within 12 months prior to randomization.
主要排除條件
Exclusion Criteria:
Documented refractoriness to lenalidomide.
Have lenalidomide exposure within 12 months prior to randomization.
Documented refractoriness to lenalidomide.
Have lenalidomide exposure within 12 months prior to randomization.
試驗計畫預計收納受試者人數
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台灣人數
10 人
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全球人數
500 人
