NCT00992732终止2 期
A Phase 2a Open-Label Multi-Center Study Evaluating HQK-1004 Administered With Valganciclovir in Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Lymphoid Malignancies or Lymphoproliferative Disorders
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 8
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to determine if treatment with HQK-1004 and valganciclovir will result in complete or partial responses in patients with EBV-positive lymphoid malignancies or lymphoproliferative disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed lymphoid malignancy or lymphoproliferative disorder with EBV detected by either immunohistochemistry or in situ hybridization. Pathology can be assessed on either a current or previous biopsy. All disease stages are eligible
- •Disease that is refractory or relapsed after at least one prior standard therapeutic regimen, which includes biologic agents (e.g., monoclonal antibodies), chemotherapy or chemoradiotherapy regimens. Prior therapy may include high dose chemotherapy and stem cell rescue or bone marrow transplantation
- •Bidimensionally measurable disease by computerized tomography (CT) or magnetic resonance imaging (MRI; patients with sensitivity to contrast or for tumor types that are less accurately measured by CT) scan or physical measurement (cutaneous lesions only) with at least 1 lesion ≥ 10 mm in the greatest diameter. PET-CT should be used at baseline for patients with Hodgkin's Disease (HD) or diffuse large B-cell lymphoma (DLBCL).
- •Absolute neutrophil count ≥ 500/mm3 and platelet count ≥ 50,000/mm3
- •Bilirubin ≤ 2.0 times upper limit of normal (ULN) with the exception of patients with Gilbert's syndrome (bilirubin ≤ 3.5 times ULN allowed), and both AST and ALT ≤ 3 times ULN
- •Serum creatinine ≤ 2.0 mg/dL
排除标准
- •Patients who have not recovered from previous treatment with chemotherapy
- •Patients who have been treated with biologic agents within two weeks prior to first dose of HQK-1004
- •Uncontrolled ischemic heart disease or uncontrolled congestive heart failure, or myocardial infarction within the past 3 months
研究组 & 干预措施
HQK-1004 + Valganciclovir
Experimental
干预措施: HQK-1004 (Drug)
HQK-1004 + Valganciclovir
Experimental
干预措施: Valganciclovir (may substitute with ganciclovir) (Drug)
结局指标
主要结局
Overall response rate
时间窗: Days 21, 42, 84 and 126
次要结局
- Safety and tolerability as measured by adverse events, physical exams, ECG, and laboratory evaluations(through end of treatment (up to Day 126) and 30 days post last dose)
- Overall and progression-free survival(through end of treatment (up to Day 126), then every 8 weeks for 1 year post last dose)
研究者
研究点 (8)
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