Phase 1 Dose Finding Study of Belinostat Plus Cyclophosphamide/Vincristine/Doxorubicin/Prednisone (CHOP) Regimen (BelCHOP) for Treatment of Patients With Peripheral T-cell Lymphoma(PTCL)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.
详细描述
This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose (MTD) of belinostat when administered in combination with CHOP.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or above
- •Life Expectancy > 3 months
- •Histologically confirmed diagnosis of PTCL
- •Patients with transformed CTCL eligible for CHOP regimen
- •Measurable disease based on Cheson 2007 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status < 2
排除标准
- •Known active Hepatitis B/ Hepatitis C/ HIV infection
- •Known, uncontrolled CNS metastases or primary CNS lymphoma
- •Deep vein thrombosis diagnosed within 3 months
- •Ongoing treatment for pre-existing cardiovascular disease
- •Neuropathy Grade 3 or more
- •Previous extensive radiotherapy except limited field RT for locally advanced nasal NK PTCL or for pain palliation
- •Prior therapy with severely myelotoxic regimens, including autologous and allogenic stem cell transplantation
- •Prior therapy with HDAC inhibitors (except for CTCL)
- •Inadequate hematological, hepatic, or renal function
研究组 & 干预措施
Dose Finding Phase
This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose of Belinostat when administered in combination with CHOP. In Part A of the study, up to three sequential dose cohorts will enroll a maximum of 6 patients each.
Enrollment will begin with the enrollment of patients into Cohort 3.
On Day 1 of each 21-day treatment cycle, the study treatment will start with belinostat followed by CHOP regimen.
干预措施: Belinostat (Drug)
Dose Finding Phase
This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose of Belinostat when administered in combination with CHOP. In Part A of the study, up to three sequential dose cohorts will enroll a maximum of 6 patients each.
Enrollment will begin with the enrollment of patients into Cohort 3.
On Day 1 of each 21-day treatment cycle, the study treatment will start with belinostat followed by CHOP regimen.
干预措施: CHOP (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: up to 5 days
To determine the MTD for belinostat when combined with CHOP regimen and establish the Phase 3 recommended belinostat dose.
次要结局
- Overall Response Rate(126 days)
- Safety and tolerance(up to 5 days)
- Effectiveness of study drug(126 days)