Targeting Bruton's Tyrosine Kinase (BTK) With Ibrutinib After Autologous Stem Cell Transplantation in "Double-Hit" B-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
The goal of this clinical research study is to learn if ibrutinib can help to control lymphoma in patients who have had an autologous stem cell transplant (a transplant using your own stem cells). The safety of this drug will also be studied.
详细描述
Study Drug Administration:
If you take part in this study, you will take ibrutinib by mouth 1 time each day for up to 3 years. You must swallow the capsules whole with a glass (about 8 ounces) of water. Do not open, break, or chew the capsules. You should take ibrutinib at the same time every day.
If you miss a dose of ibrutinib, take it as soon as you remember on the same day. Take your next dose of ibrutinib at your regular time on the next day. Do not take 2 doses of ibrutinib on the same day to make up for a missed dose.
You will be given a study drug diary to write down what time you take each dose of ibrutinib. You need to bring the study drug diary, any leftover study drug, and any empty study drug containers with you to each visit.
The dose of ibrutinib you receive may be lowered, if the doctor thinks it is needed.
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 newly diagnosed double hit in first complete remission, anytime during the first 3 months after chemoimmunotherapy followed by autologous stem cell transplantation if there was no evidence of progression.
- •Double hit lymphoma is defined as B-cell lymphoma with genetic abnormalities involving A) and in addition, B) and/or C): A) C-MYC arrangement or amplification by FISH study. B) BCL2 rearrangement or amplification by FISH study. C) BCL6 rearrangement or amplification by FISH study.
- •ANC >/= 1,000, platelets >/= 75,
- •AST and/or ALT < 3 times the ULN.
- •Creatinine clearance > 30 ml/min (Cockcroft-Gault formula using ideal body weight).
- •Male or female age >/= 18 years.
- •ECOG performance status </=
- •Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.
- •Patient should preferably have received a pre-transplant conditioning with rituximab and Carmustine/Etoposide/Cytarabine/Melphalan/Rituxan (BEAM/R) . Other regimens which are similar may be accepted at the discretion of the PI.
排除标准
- •Prior chemotherapy within 3 weeks, nitrosoureas (carmustine) within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug.
- •Relapsed within three months post transplant.
- •History of other malignancies within the past year except for treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- •Known CNS lymphoma.
- •Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- •Requires treatment with a strong cytochrome P450 (CYP)3A inhibitor (i.e. Voriconazole, posaconazole, itraconazole, clarithromycin, etc.) or inducer (carbamazepine, rifampin, phenytoin, etc.).
- •AST and/or ALT >/= 3 times the ULN.
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or symptomatic ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- •Known history of human immunodeficiency virus or active infection with hepatitis C virus or hepatitis B virus or any uncontrolled active systemic infection.
- •Positive pregnancy test in women of childbearing potential.
- •Lactating or pregnant or will not agree to use contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear children.
- •Concomitant use of warfarin or other Vitamin K antagonists.
研究组 & 干预措施
Ibrutinib
Ibrutinib started at a daily dose of 560 mg by mouth daily for up to 3 years.
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: Two years
Participants will be assessed for disease status and survival.
次要结局
- Overall Survival (OS)(Three Years)