Ofatumumab for Residual Disease and Maintenance Following Chemotherapy or Chemoimmunotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Patients With Objective Response
研究概览
简要总结
The goal of this clinical research study is to find out if ofatumumab can control CLL or SLL that is left after chemotherapy or chemoimmunotherapy. The safety of the drug will also be studied.
详细描述
The Study Drug:
Ofatumumab is designed to bind to the surface of some white blood cells (B-cells) and to kill these cells. It can destroy cancer cells that come from B-cells, and can be used to treat cancers of B-cells such as B-CLL.
Study Drug Administration If you are found to be eligible to take part in this study, you will receive ofatumumab up to 20 times during this study. You will receive 8 weekly infusions and then an infusion every 2 months for 2 years or until the disease gets worse. You will receive ofatumumab by vein over about 6 ½ hours the first time and over 4 hours for all the following infusions. The first infusion will be the smallest dose. The second and later infusions will be 3 times larger than the first.
Before you receive the study drug each time, you will receive Tylenol (acetaminophen) by mouth to reduce the risk of fever. You will receive Benadryl (diphenhydramine) by mouth or vein and prednisolone (a steroid) by vein over about 30 minutes to reduce the risk of an allergic reaction or an infusion reaction.
During the infusions, you will be monitored closely. You will be expected to stay in clinic for about 71/2 hours on the day of the first infusion and 5 hours for all other infusions.
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
- •Diagnosis of CD20+ chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated with chemotherapy or chemoimmunotherapy: Post-frontline therapy, patients must have non-progressing disease and be 4 months to 1 year post treatment. Post-treatment for relapsed CLL, eligible patients must have non-progressing disease and be 3 months to 1 year post treatment.
- •Patients (CR, nPR, or PR at enrollment) must have measurable disease, which may include MRD by 4-color flow cytometry.
- •Adequate renal and hepatic function (creatinine < 2 mg/dL, bilirubin < 2 mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. Patients with Gilbert's syndrome are eligible.
- •Age >/= 18 years.
- •ECOG performance status of 0-
- •Provide informed consent indicating patient is aware of the investigational nature of this study according to the policies of the MDACC IRB.
- •Patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study.
排除标准
- •Positive serology for Hepatitis B virus (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
- •Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not comprising bone marrow function does not apply.
- •Active infection or significant medical illness, including current active hepatic or biliary disease (with exception of patients with asymptomatic gallstones, liver involved with CLL or stable chronic liver disease per investigator assessment).
- •Pregnant and breastfeeding females are excluded.
研究组 & 干预措施
Ofatumumab
Ofatumumab 300 mg dose 1, then 1,000 mg weekly * 7, (treatment) then 1,000 mg every 2 months beginning on week 12 for a total of 2 years of treatment or until progression (maintenance) of disease. The follow-up period will be the period after completion of maintenance.
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Number of Patients With Objective Response
时间窗: Week 12
Response assessment according to 2008 International Working Group for CLL (IWCLL), prior to 9th dose of ofatumumab (prior to first bimonthly dose). Responses of (complete remission (CR) conversion to minimal residual disease (MRD) negative, partial remission (PR) conversion to nodular partial remission nPR or CR, and nPR conversion to complete remission (CR)) evaluated by physical examination, CBC, CT of chest, abdomen, pelvis, and bone marrow aspirate and biopsy with evaluation of residual disease (MRD) by 4-color flow cytometry.
次要结局
- Time-to-Treatment Failure (TTF)(Start of study drug up to approximately 1 year and 7 months.)
- Progression-Free Survival (PFS)(Start of study drug up to approximately 7 years and 6 months.)