2021-10-01 - 2027-12-31
Phase II
召募中8
一項針對罹患 Epstein-Barr 病毒陽性 (EBV+) 復發型/難治型淋巴瘤患者，使用 Nanatinostat 併用 Valganciclovir 的開放標示、第 2 期試驗 (NAVAL-1)
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試驗申請者
保瑞爾生技股份有限公司
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試驗委託 / 贊助單位名稱
Viracta Therapeutics, Inc.
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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
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
試驗目的
藥品名稱
錠劑
主成份
Valganciclovir
劑型
110
劑量
450mg
評估指標
根據獨立審查委員會 (IRC) 使用 2007 年國際工作小組 (IWG) 標準評估的客觀反應率 (ORR)
Primary:
• Objective response rate (ORR) as assessed by an Independent Review Committee (IRC) – per the 2007 International Working Group (IWG) criteria.
主要納入條件
1. Adult patients age ≥18 years at the time of informed consent.
2. For ENKTL patients only: Relapsed or refractory disease following 1 or more prior systemic therapies. Patients must have failed an asparaginase-containing regimen.
3. For non-ENKTL patients only: Relapsed or refractory disease
following 2 or more prior systemic therapies with the following specifications:
a. EBV+ DLBCL, NOS: Must have received at least one course of an anti CD20 immunotherapy and at least one course of anthracycline-based chemotherapy.
b. PTLD: Must have received immunotherapy with an anti-CD20 agent.
c. Hodgkin lymphoma: Must have received at least one course of
anthracycline-basedchemotherapy. Patients with Hodgkin lymphoma should have failed or be ineligible for an anti-PD1 agent and CB30-directed therapy.
4. No available therapies in the opinion of the Investigator.
5. Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy.
6. Measurable disease at baseline per Lugano 2007
7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
8. Adequate bone marrow function.
主要排除條件
1. Presence or history of central nervous system (CNS) involvement by lymphoma.
2. Systemic anticancer therapy or CART within 21 days. .
3. Antibody (anticancer) agents within 28 days
4. Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant.
5. Less than 90 days from prior allogeneic transplant.
6. Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1.
7. Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
8. Active infection requiring systemic therapy (excluding viral upper respiratory tract infections).
試驗計畫預計收納受試者人數
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台灣人數
30 人
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全球人數
486 人
