A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies
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
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Freiburg、德国、79106
- Novartis Investigative Site
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Hamburg、德国、20246
- Novartis Investigative Site
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Jena、德国、07740
- Novartis Investigative Site
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Koeln、德国、50937
- Novartis Investigative Site
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Bavaria
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Regensburg、Bavaria、德国、93053
- Novartis Investigative Site
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Paris、法国、75010
- Novartis Investigative Site
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Basel、瑞士、4031
- Novartis Investigative Site
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Zürich、瑞士、8091
- Novartis Investigative Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- 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
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Study Part 1: KRP203
All patients to receive KRP203 for 111days
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All subjects will receive KRP203 for 111 days
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实验性的：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
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实验性的：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
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with Adverse Events as a Measure of safety
大体时间：111 days
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Safety and tolerability of KRP203 in patients undergoing allogeneic hematopoetic stem cell transplant for hematological malignancies
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111 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Plasma Pharmacokinetics of KRP203: Area under the Plasma Concentration-time Curve (AUC)
大体时间：111 days
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The main PK parameters will be determined in whole blood using non-compartmental methods.
Pk parameters being measured are: AUCtau AUC during a dosing interval (tau) of 24 hours [h.ng/mL] , AUCtauR Molar ratios between KRP203-P and KRP203 based on Cmax or AUCtau
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111 days
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Plasma Pharmacokinetics (PK) of KRP203: Observed Maximum Plasma Concentration Following Drug Administration (Cmax)
大体时间：111 days
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Cmax Maximum (peak) blood drug concentration after drug administration [ng/mL]
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111 days
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Plasma Pharmacokinetics (PK) of KRP203: Time to reach the maximum concentration after drug administration
大体时间：111 days
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Tmax Time to reach maximum (peak) concentration [ng/mL]
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111 days
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GVHD-free, relapse free survival
大体时间：1 years post-transplant
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occurence of GVHD, disease relaps and death will be assessed
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1 years post-transplant
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GVHD-free, relapse free survival
大体时间：2 years post transplant
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occurence of GVHD, disease relaps and death will be assessed
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2 years post transplant
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.