Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)
2019年2月28日 更新者：Merck Sharp & Dohme LLC
An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma
This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single agent, for participants with B-lymphocyte antigen cluster of differentiation 20 (CD20)-positive follicular lymphoma who have had no prior chemotherapy.
The primary study hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a single agent.
研究概览
详细说明
The study was terminated early by the Sponsor due to business reasons.
All participants were discontinued from MK-8808 + CVP, but could continue to receive maintenance therapy with MabThera™ (rituximab) per standard of care.
研究类型
介入性
注册 (实际的)
7
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Histological diagnosis of CD20-positive follicular lymphoma, Grade 1, 2, or 3a (World Health Organization [WHO] 2008 classification) based on an excisional or incisional lymph node biopsy or a bone marrow biopsy.
- Ann Arbor Stage III or IV disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Life expectancy >3 months with no expected need of immediate intervention to treat life-threatening complications.
- Adequate organ function.
- Participants must agree to use an adequate method of contraception starting with the first dose of study drug through 12 months (for females) or 90 days (for males) after the last dose of study drug.
Exclusion criteria:
- Histological Grade 3b or with >50% diffuse architectural pattern.
- Circulating malignant cells >25,000/mm^3
- Presence or history of central nervous system (CNS) disease (either CNS lymphoma or lymphomatous meningitis).
- Prior treatment with chemotherapy, rituximab, any other anti-CD20 compound, or any other type of anti-cancer compounds.
- Radiotherapy within 2 months prior to Cycle 1 Day 1.
- Current participation or has participated in a study with an investigational compound within 30 days prior to Cycle 1 Day 1.
- Concomitant disease that requires continuous therapy with prednisone at doses >20 mg per day.
- Any medical contraindication for prednisolone as being dosed in the CVP regimen.
- Poorly controlled diabetes mellitus, as defined by institutional or local standards.
- Grade >2 peripheral neuropathy.
Has one of the following:
- is human immunodeficiency virus (HIV)-positive
- is Hepatitis B surface antigen positive (HBsAg+) or is positive for antibodies to Hepatitis B core antigen (anti-HBcAg+)
- has antibodies to Hepatitis C virus
Has one or more of the following:
- Active tuberculosis based on institutional diagnostic criteria and local practice guidelines.
- Evidence of a tuberculosis infection based on a chest X-ray (CXR) or computed tomography (CT) scan performed within 3 months of dosing.
- History of a tuberculosis infection.
- Major surgical procedure within 4 weeks prior to Cycle 1 Day 1.
- Regular use (including "recreational" use) of any illicit drugs or recent history (within the last year) of drug or alcohol abuse or dependence.
- Pregnant or breastfeeding.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：MK-8808 Combination Therapy
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles.
Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
|
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 |
|---|---|---|
|
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy
大体时间：From first dose of combination therapy up to 24 weeks
|
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
|
From first dose of combination therapy up to 24 weeks
|
|
Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy
大体时间：From first dose of single agent MK-8808 up to 2 years
|
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
|
From first dose of single agent MK-8808 up to 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP
大体时间：Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
|
Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.
|
Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
|
|
Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy
大体时间：Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
|
Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.
|
Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
|
|
Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP
大体时间：Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
|
Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.
|
Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
|
|
Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance
大体时间：Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
|
Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.
|
Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
|
|
Clinical Response of Tumor to MK-8808/CVP Combination Therapy
大体时间：Up to 2 years
|
The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST).
Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review.
|
Up to 2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年8月19日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2011年5月18日
首先提交符合 QC 标准的
2011年6月9日
首次发布 (估计)
2011年6月10日
研究记录更新
最后更新发布 (实际的)
2019年3月15日
上次提交的符合 QC 标准的更新
2019年2月28日
最后验证
2019年2月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 8808-001
- 2011-000386-13 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
研究数据/文件
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.
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