A Two-part, Single- and Two Arm Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy (in Part 2 Only) of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies
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
- Number of participants with Adverse Events as a Measure of safety
研究概览
简要总结
Two part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy (in Part 2 only) of KRP203 in patients undergoing allogeneic hemopoietic stem cell transplant for hematological malignancies
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 65 years, inclusive
- •Patients must have a hematological malignancy that as per standard medical practice requires myeloablative conditioning (including short term myeloablative reduced intensity conditioning) followed by allogeneic hematopoetic stem cell transplant
- •Karnofsky Performance status ≥60%.
- •Suitable stem cell source available according to the graft selection algorithm using T-cell replete peripheral stem cells as a graft source
排除标准
- •Resting heart rate below 55
- •Significant cardiac disease (such as arrhytmia, heart failure) or any significant condition which in the investigators opinion would make the patient ineligible
- •Previous allogeneic HSCT
- •Any drug required that is not compatible with KRP203 (e.g. beta-blockers or anti-thymocyte globulin)
研究组 & 干预措施
Study Part 1: KRP203
All patients to receive KRP203 for 111days
干预措施: Study Part 1: KRP203 (Drug)
Study Part 2: lower KRP203 dose
in this treatment arm patients will receive the lower KRP203 dose for 111 days on top of the standard treatment with cyclosporine A and methotrexte for GVHD prophylaxis
干预措施: Study Part 2: KRP203 lower dose (Drug)
Study Part 2: higher KRP203 dose
in this treatment arm patients will recieve the higher KRP203 dose for 111 days on top of standard treatment with tacrolimus and methotrexate for GVHD prophylaxis
干预措施: Study Part 2: KRP203 higher dose (Drug)
结局指标
主要结局
Number of participants with Adverse Events as a Measure of safety
时间窗: 111 days
Safety and tolerability of KRP203 in patients undergoing allogeneic hematopoetic stem cell transplant for hematological malignancies
次要结局
- GVHD-free, relapse free survival(2 years post transplant)
- Plasma Pharmacokinetics of KRP203: Area under the Plasma Concentration-time Curve (AUC)(111 days)
- Plasma Pharmacokinetics (PK) of KRP203: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)(111 days)
- Plasma Pharmacokinetics (PK) of KRP203: Time to reach the maximum concentration after drug administration(111 days)
- GVHD-free, relapse free survival(1 years post-transplant)