CTIS2024-512717-41-00招募中1 期
An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1) - VT3996-202
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 502
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •1. Adult patients age =18 years or as permitted by applicable local regulations at the time of providing informed consent. Patients must be able to swallow whole tablets. a. For patients with PTLD: Age =12 years and weighing =40 kg, 10. Measurable disease per Lugano 2007., 11. ECOG performance status 0, 1, 2., 12. Adequate bone marrow function., 2. EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies, 3. Patients must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy, 4. Hodgkin lymphoma: Must have received at least one course of antracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy., 5. For patients with ENKTL: Relapsed/refractory disease following 1 or more prior systemic therapies. Patients must have failed an a sparaginase-containing regimen., 6. For patients with PTCL (PTCL, NOS and AITL): relapsed or refractory disease following 1 (2 for France) or more prior systemic therapies with a curative intent., 7. For patients with PTLD: Patients with relapsed or refractory EBV+ PTLD who have received at least one prior therapy must have received at least one course of an antiCD20 immunotherapy such as rituximab. For solid-organ transplant (SOT) patients, prior therapy also includes chemotherapy, administered concurrently or sequentially, unless chemotherapy is inappropriate., 8. No available therapies in the opinion of the investigator., 9. Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T Therapy.
排除标准
- •1. Presence or history of central nervous system (CNS) involvement by lymphoma., 2. Systemic anticancer therapy or CAR 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.
研究者
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