A Pilot Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Participants With >/= 95 % Bruton's Tyrosine Kinase (BTK) Occupancy
研究概览
简要总结
Ibrutinib is currently FDA approved and commercially available for the treatment of CLL. However, some researchers think the approved dose may be unnecessarily high.
The goal of this clinical research study is to compare 3 different daily doses of ibrutinib to learn how these doses affect the disease and your body. Researchers think that if a lower dose of ibrutinib can be found to be as effective as the currently approved dose this may help to lower the risk of side effects.
详细描述
Study Drug Administration:
Each study cycle is 28 days.
If you are found to be eligible to take part in this study, you will take ibrutinib capsules by mouth every day for 3 cycles. Each dose of ibrutinib should be taken at about the same time, either with or without food.
During Cycle 1, you will receive the highest dose of ibrutinib (the dose that is currently FDA approved). You will take 3 capsules each day during Cycle 1. During Cycle 2, you will receive the second-highest dose and you will take 2 capsules each day. During Cycle 3, you will take the lowest dose of ibrutinib and you will take 1 capsule each day.
You must swallow the ibrutinib capsules whole without opening, breaking, or chewing them.
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
- •Patients with a diagnosis of CLL (any stage) with ALC >/= 20 x 109/l, requiring therapy.
- •Able to receive ibrutinib through commercial supply, i.e., insured patients meeting FDA-approved indications.
- •Age >/=18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Adequate end organ function, defined as the following: total bilirubin </= 1.5 x upper limit of normal (ULN, unless due to Gilbert syndrome, in which case it should be </= 3.0 x ULN), ALT and AST </= 2.5 x ULN, CrCL >/= 25 ml/min.
- •Able to understand and sign the IRB-approved informed consent document for this trial.
- •Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study. Male patients who are partners of WOCBP should also practice an effective method of contraception. Effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization. Postmenopausal women must be amenorrheic for >/= 12 months to be considered of non-childbearing potential, Women and men must continue birth control for the duration of the trial and >/= 3 months after the last dose of study drug, All WOCBP MUST have a negative pregnancy test prior to beginning ibrutinib on study.
- •Patients should have discontinued any and all other therapy for CLL >/= 48 hours prior to start of study therapy and recovered from any toxicity due to these therapies to grade </= 1.
排除标准
- •Previous treatment with ibrutinib.
- •Current therapy with warfarin or other anticoagulants at therapeutic doses, e.g., low molecular weight heparin, fondaparinux, dabigatran, rivaroxaban, apixaban or edoxaban that are unable to be discontinued.
- •Active gastrointestinal conditions that are expected to impair absorption of orally administered medications.
- •Active, uncontrolled infection.
- •History of hypersensitivity to ibrutinib.
- •Pregnancy or lactation.
- •Patients with leukemic involvement of the central nervous system.
- •Patients who currently have or have a history of the following within 6 months preceding study entry are not eligible: Unstable angina (UA) or myocardial infarction (MI), Clinically significant atrial or ventricular arrhythmias (e.g., AF, atrial flutter, ventricular tachycardia, ventricular fibrillation, or torsades de pointes), New York Heart Association (NYHA) class III or IV heart failure.
- •Patients on strong CYP3A inducers or inhibitors that are unable to be discontinued. The list of drugs that interact with cytochrome P450 enzymes can be found online at: http://medicine.iupui.edu/clinpharm/DDIs/ClinicalTable.aspx
研究组 & 干预措施
Ibrutinib
Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.
During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Participants With >/= 95 % Bruton's Tyrosine Kinase (BTK) Occupancy
时间窗: 3 cycles, up to 90 days
BTK occupancy level measured by fluorescent affinity probe just before dosing and at 4 and 24 hours post-dosing on days 1, 8, and 28 (but before the first dose of the next cycle) of each cycle.
次要结局
未报告次要终点