Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
2015年7月2日 更新者：GlaxoSmithKline
An Open-label, Single-arm. Multi-center Phase 2 Trial With Ofatumumab in Patients With Relapsed/Progressive Diffuse Large B-Cell Lymphoma (DLBCL) Ineligible for Transplant or Relapse/Progression After Autologous Transplant
The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant
研究概览
研究类型
介入性
注册 (实际的)
81
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
London、英国、EC1M 6BQ
- GSK Investigational Site
-
-
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:
Patients with DLBCL
- and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation
- and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.
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：非随机化
- 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：Ofatumumab
8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
|
8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg
|
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 With Objective Response
大体时间：6-month period from start of treatment (up to Week 24)
|
Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma."
Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease.
CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.
|
6-month period from start of treatment (up to Week 24)
|
|
Number of Participants Classified as Responders and Non-responders for Objective Response
大体时间：6-month period from start of treatment (up to Week 24)
|
According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD).
Participants not evaluable (NE) were also considered to be non-responders.
PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline.
SD is defined as failure to attain CR, PR, or PD.
|
6-month period from start of treatment (up to Week 24)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of Response
大体时间：From date of start of treatment to 2 years or withdrawal
|
The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death.
If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.
|
From date of start of treatment to 2 years or withdrawal
|
|
Progression-free Survival (PFS)
大体时间：From date of start of treatment to 2 years or withdrawal
|
PFS was defined as the time from treatment start until progression or death.
|
From date of start of treatment to 2 years or withdrawal
|
|
Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy
大体时间：From date of start of treatment to 5 years or withdrawal
|
Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab.
If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.
|
From date of start of treatment to 5 years or withdrawal
|
|
Overall Survival (OS)
大体时间：From date of start of treatment to 5 years or withdrawal
|
Overall survival is defined as the time from first infusion to death.
Overall survival was a secondary endpoint in the study.
However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.
|
From date of start of treatment to 5 years or withdrawal
|
|
Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18
大体时间：Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
|
HAHA are indicators of immune response to ofatumumab.
Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches.
The number of participants with positive results at each visit is reported.
|
Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)
|
|
Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits
大体时间：Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)
|
B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry.
Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100.
|
Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)
|
|
Number of Participants Who Experienced at Least One Adverse Event (AE)
大体时间：Time frame is from date of start of treatment to 2 years or withdrawal
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).
|
Time frame is from date of start of treatment to 2 years or withdrawal
|
|
Percent Change From Screening in Complement (CH50) Levels
大体时间：Screening and post-baseline visits (last visit was to occur 24 months post first dose)
|
CH50 was mistakenly registered as an outcome measure with the protocol record.
Samples were not collected, and no analysis will take place.
Thus, no data will be reported for this outcome measure.
|
Screening and post-baseline visits (last visit was to occur 24 months post first dose)
|
|
AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion
大体时间：Visit 9 (Week 7; up to 11 months after last dose)
|
AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure.
AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.
|
Visit 9 (Week 7; up to 11 months after last dose)
|
|
Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions
大体时间：Visit 2 (Week 0) and Visit 9 (Week 7)
|
Cmax is defined as the maximum concentration of drug in serum samples.
Ctrough is defined as the minimum observed concentration prior to the start of the next dose.
No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.
|
Visit 2 (Week 0) and Visit 9 (Week 7)
|
|
Half-life (T1/2) for Ofatumumab at the Eighth Infusion
大体时间：Visit 9 (Week 7; up to 11 months after last dose)
|
t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.
|
Visit 9 (Week 7; up to 11 months after last dose)
|
|
Clearance (CL) of Ofatumumab at the Eighth Infusion
大体时间：Visit 9 (Week 7; up to 11 months after last dose)
|
CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.
|
Visit 9 (Week 7; up to 11 months after last dose)
|
|
Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion
大体时间：Visit 9 (Week 7; up to 11 months after the last dose)
|
Vss is the volume of distribution at steady state of ofatumumab.
|
Visit 9 (Week 7; up to 11 months after the last dose)
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2007年12月1日
初级完成 (实际的)
2010年5月1日
研究完成 (实际的)
2014年8月1日
研究注册日期
首次提交
2008年2月13日
首先提交符合 QC 标准的
2008年2月13日
首次发布 (估计)
2008年2月25日
研究记录更新
最后更新发布 (估计)
2015年7月24日
上次提交的符合 QC 标准的更新
2015年7月2日
最后验证
2015年1月1日
更多信息
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.