A Phase 2, Multicenter, Open Label Dose-ranging Study of Sepantronium Bromide in Patients With Relapsed/Refractory c-Myc Rearranged High-grade B-cell Lymphoma (HGBCL)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
- 试验地点
- 11
- 主要终点
- Safety and tolerability and recommended Phase 2 dose of sepantronium bromide
研究概览
简要总结
This is a multi-center Phase 2 study to determine the safety and efficacy of sepantronium bromide (SepB) in adult patients with relapsed or refractory high-grade B-cell lymphoma
详细描述
This is a multi-center, open label, dose-ranging Phase 2 study evaluating the safety and efficacy of SepB in patients with relapsed/refractory c-Myc rearranged HGBCL.
Cohorts of three patients will be enrolled at each dose level for SepB with expansion to six patients, if necessary, to assess toxicity.
Following the completion of 2 cycles of treatment of each cohort, an independent Data Monitoring Committee (DMC) will review the safety data to assess study drug related toxicities from the current cohort. Following this review, a decision will be made to continue dose escalation to the next dose level, to declare that a given dose level is the level of dose-limiting toxicity (DLT) or to further explore toxicity at the dose level in question by enrolling additional subjects to a maximum of six subjects at that level.
An additional 6 patients will be enrolled at the recommended Phase 2 dose (RP2D). The RP2D will be established on the basis of the maximally tolerated dose between the two specified dose levels as well as other relevant data, including clinical signals of activity, pharmacokinetic (PK) and pharmacodynamic (PD) data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed histologic diagnosis of c-Myc rearranged high-grade B-cell lymphoma
- •Relapse or refractory disease after at least one previous line of therapy
- •Measurable disease as defined by 2014 Lugano classification
- •ECOG performance status of 0-2
- •Acceptable coagulation parameters
排除标准
- •Allogeneic transplant within 3 months
- •Autologous transplant without resolution of post-transplant cytopenias
- •Known CNS involvement
- •Average QT/QTc interval duration > 450 msec
- •Inadequate marrow, hepatic or renal function
- •Unresolved Grade 2 or greater toxicities from prior anticancer therapy
- •Radiotherapy within prior 4 weeks
- •Requires systemic immunosuppressive therapy
- •Positive for Hepatis B or Hepatis C
- •Seropositive for HIV
研究组 & 干预措施
Cohort 1
Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide
干预措施: Sepantronium Bromide (Drug)
Cohort 2
Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide
干预措施: Sepantronium Bromide (Drug)
Recommended Phase 2 Dose - Cohort 3
The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2
干预措施: Sepantronium Bromide (Drug)
结局指标
主要结局
Safety and tolerability and recommended Phase 2 dose of sepantronium bromide
时间窗: From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions
次要结局
- Overall response rate(From first dose through the last dose of study drug, an average of 6 months)
- Complete response rate(From first dose of study drug through the last dose of study drug, an average of 6 months)
- Duration of response(From first dose of study drug through to time of progression, an average of 6 months)
- Clinical benefit rate(From first dose of study drug through the last dose of study drug, an average of 6 months)
- Overall survival(From first dose of study drug through date of death, irrespective of cause, an average of 6 months)
- Progression Free Survival(From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months)