jRCT2061240096招募中不适用
A Multi-Center, Global, Open-Label, Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Intravenous Brincidofovir in Patients With Relapsed or Refractory Lymphoma As Well As to Evaluate the Safety and Efficacy of Intravenous Brincidofovir in Patients With Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma Using The Recommended Phase 2 Dose (BCV-NL01)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 43
- 主要终点
- Adverse events (AEs) that meet the protocol-defined DLT criteria in Cycle 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who are histopathologically diagnosed with ENKL based on the World Health Organization (WHO) Classification of Malignant Lymphoma 5th Edition (WHO-HAEM5) (can be enrolled in the Phase 1b part and the Phase 2 part) or patients diagnosed with EBV-positive nodal T- and NK-cell lymphoma (EBV + nTNKCL), nodal T-follicular helper cell lymphoma (nTFHcL) (including angioimmunoblastic T-cell lymphoma (AITL) as defined in the WHO Classification, 4th Edition), peripheral T-cell lymphoma not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), diffuse large B-cell lymphoma (DLBCL) (e.g., DLBCL, NOS), or adult T-Cell Leukemia Lymphoma (ATLL) (can only be enrolled in the Phase 1b part)
- •Patients with relapsed or refractory lymphoma and previously treated with systemic chemotherapy (history of multidrug chemotherapy including L-asparaginase such as SMILE therapy for ENKL is mandatory) who are ineligible for other systemic therapies
- •Patients with the following Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):
- •Phase 1b part: 0-1
- •Phase 2 part: 0-2
排除标准
- •Patients with another active malignant tumor requiring treatment
- •Patients with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 2 or higher diarrhea (increase of 4 or more bowel movements per day compared to usual number of bowel movements) within 7 days prior to starting the first dose of BCV
- •Graft-Versus-Host Disease (GVHD) patients requiring immunosuppressive agents
- •Patients with a history of CDV intolerance
- •Patients with a history of being diagnosed with cirrhosis
结局指标
主要结局
Adverse events (AEs) that meet the protocol-defined DLT criteria in Cycle 1
时间窗: Cycle 1
Adverse events (AEs) that meet the protocol-defined DLT criteria in Cycle 1 and the number of participants that developed these AEs
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: after initiation of BCV treatment
Incidence of treatment-emergent adverse events (TEAEs) after initiation of BCV treatment (particularly the incidence of AEs and serious adverse events [SAE] of NCI-CTCAE Grade 3 or higher)
PK exposure dose by participants
PK exposure dose by participants estimated using population PK analysis (maximum plasma concentration [Cmax] and the area under the concentration-time curve [AUC], etc.)
Best Overall Response
时间窗: end of treatment (EOT)
Best Overall Response as of end of treatment (EOT)
次要结局
未报告次要终点
研究者
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