NCT01848145已完成2 期
Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia, a Phase II Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Percent of Patients Who Complete an Accelerated Infusion Regimen Within 15 Minutes of the Planned 2-hour Treatment.
研究概览
简要总结
This is a Phase II, single-arm study of ofatumumab investigating the safety of an accelerated infusion schedule of ofatumumab in patients who have received at least one prior therapy for CLL. The primary endpoint is to evaluate the number of subjects able to complete infusion number 3 (2000 mg) within 15 minutes of the planned time.
详细描述
The purpose of this study is to develop an accelerated infusion regimen that allows ofatumumab to be delivered in a safe manner while minimizing the time required administering the treatment. We hypothesize there will be fewer infusion-related reactions using the proposed dose-dense approach the first week before accelerating the rate of infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD20+ B-cell chronic lymphocytic leukemia (B-CLL) according to International Workshop on CLL Working Group (IWCLL WG) Diagnostic Criteria.
- •Have received at least one prior therapy for CLL.
- •If previously treated with ofatumumab must have achieved at least a partial response (PR) and maintained PR for >= 6 months.
- •Requires treatment according to IWCLL-Working Group guidelines.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) <=
- •Laboratory parameters <=7 days prior to treatment initiation:
- •Creatinine <= 1.5 mg/dL upper limit normal (ULN)
- •Aspartate amino transferase (AST) or alanine amino transferase (ALT) <= 3.0 x ULN
- •Alkaline phosphatase (ALP) <= 3.0 x ULN
- •Total Bilirubin level of < 1.5 mg/dL x the institutional ULN unless secondary to Gilbert's disease (or pattern consistent with Gilbert's)
- •Hepatitis B sAg negative and HepB cAb negative. Note: Patients who are HepB sAg negative but are HepB cAb positive (regardless of HepB sAb status) will NOT be allowed.
- •Women of childbearing potential must have a negative serum pregnancy test performed <=72 hours prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
- •Accessible for treatment and follow-up.
- •Able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.
- •No prior antibody therapy for CLL within the previous 3 months.
排除标准
- •Previous treatment with ofatumumab that resulted in a Grade 3 or 4 infusion reaction.
- •Treatment for CLL within last 4 weeks. (Patients who have received steroids or IVIG for autoimmune complications of CLL are eligible).
- •Current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease, per assessment by the treating physician).
- •Active bacterial or viral infection or infection requiring intravenous antibiotic treatment at the time of accrual.
- •Central nervous system lymphoma/CLL.
- •Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (i.e., Richter's transformation).
- •History of other malignancy <= 2 years of study entry which could affect compliance with the protocol or interpretation of results. History of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, low grade, early-stage, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ (DCIS) of the breast treated with curative intent, are generally eligible.
- •Active hepatitis B or C or known HIV positive.
- •Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to visit 1, whichever is longer.
- •History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae.
- •Clinically significant cardiac disease including unstable angina, acute myocardial infarction (within 6 months of enrollment), congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
- •Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.
研究组 & 干预措施
Ofatumumab
Experimental
Rapid Infusion of Ofatumumab
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Percent of Patients Who Complete an Accelerated Infusion Regimen Within 15 Minutes of the Planned 2-hour Treatment.
时间窗: At Week 2, Day 1 of therapy
Defined as percent of patients who are able to complete the Day 8 (2000 mg IV Ofatumumab) infusion within 15 minutes of the planned 2-hour treatment goal.
次要结局
- Overall Survival(For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.)
- Duration of Time to Complete Individual Infusions of an Accelerated Infusion Schedule of Ofatumumab(Week 1 - Days 1 and 3, and Week 2, Day 1)
- Overall Response Rate (ORR)(At weeks 12 and 28)
- Progression Free Survival(For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.)
- Number of Patients With Infusion-related Reactions Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0.(up to 28 weeks)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLLSmall Lymphocytic LymphomaCLL (Chronic Lymphocytic Leukemia)NCT01145209National Heart, Lung, and Blood Institute (NHLBI)32
已完成
2 期
Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT01444716M.D. Anderson Cancer Center34
进行中（未招募）
1 期
Phase II Trial of Single Agent Ofatumumab in Relapsed / Refractory Mantle Cell Lymphoma - Ofatumumab StudyRelapsed or refractory Mantle Cell LymphomaMedDRA version: 14.1 Level: PT Classification code 10026800 Term: Mantle cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: PT Classification code 10026801 Term: Mantle cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-017675-16-GBPlymouth Hospitals NHS Trust34
已完成
2 期
An Open-Label Phase 2 Study of Ofatumumab (Arzerra) in Combination With Oral GSK2110183 in the Treatment of Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia (CLL)NCT01532700University Health Network, Toronto28
终止
2 期
Patients With Relapsed or Refractory Diffuse Large B Cell Non Hodgkin LymphomasNon-Hodgkin LymphomasNCT01078922Oncology Specialists, S.C.11