Itacitinib + Everolimus in Hodgkin Lymphoma
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University of Pennsylvania
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信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | January 2019 | ||
| 预计主要完成日期 | January 2026 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Phase I: Collection of dose-limiting toxicities of combination treatment with itacitinib and everolimus.[ Time Frame: 30 Days ] To evaluate dose-limiting toxicities (DLTs) of combination treatment with itacitinib and everolimus occurring up to and during Day 28 of Cycle 1, and to establish a recommended Phase II dose (RP2D) in subjects with relapsed or refractory cHL. Phase II: Efficacy of itacitinib in combination with everolimus[ Time Frame: 2 Years ] Evaluate the efficacy of itacitinib in combination with everolimus in subjects with relapsed or refractory cHL as demonstrated by complete response (CR) rate |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Itacitinib + Everolimus in Hodgkin Lymphoma | ||
| 正式标题 ICMJE | An Open-Label Phase I/II Safety and Efficacy Study of Itacitinib In Combination With Everolimus In Subjects With Relapsed/Refractory Classical Hodgkin Lymphoma | ||
| 简要概况 | This is an open-label, single-group, Phase I/II study of itacitinib in combination with everolimus in subjects with relapsed or refractory classical Hodgkin lymphoma (cHL). |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1/Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
28 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | January 2027 | ||
| 预计主要完成日期 | January 2026 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Able to understand and voluntarily sign the informed consent form. 2. Aged 18 years or older at the time of signing the informed consent form. 3. Biopsy-proven diagnosis of relapsed classical Hodgkin lymphoma. 4. Measurable disease on imaging defined as at least one lesion that can be accurately measured in at least two dimensions by imaging (PET/CT, CT or MRI). Minimum measurement must be ≥ 15mm in the longest axis or ≥ 10mm in the short axis. 5. Relapsed or refractory disease (after at least 2 prior systemic therapies); patients must have relapsed after high-dose therapy with ASCT, or have been deemed ineligible for high-dose therapy with ASCT based upon the below criteria: - Patients that have either progressed after treatment with, be intolerant to, or are not a candidate for brentuximab and pembrolizumab or nivolumab. The reason for forgoing such therapies must be clearly documented. - Are not ASCT candidates due to chemo-resistant disease (unable to achieve CR or PR to salvage chemotherapy), advanced age (≥ 65 years of age), or any significant coexisting medical condition (renal, pulmonary, or hepatic dysfunction) likely to have a negative impact on tolerability of ASCT - Disease free of other malignancies for greater than or equal to 2 years with the exception of basal cell, squamous cell carcinomas of the skin, fully excised melanoma in situ, carcinoma in situ of the cervix or breast. 6. Performance status of ECOG 0-2 (Appendix 13.3). 7. Laboratory test results within these ranges (of note, patients who have cytopenias due to documented cHL involvement of the bone marrow may be considered for enrollment after discussion with the PI, Medical Director and Sponsor): - Absolute neutrophil count (ANC) > 1,000/µL - Platelet count > 75,000/µL - Serum creatinine < 2.0 mg/dL - Bilirubin < 2.0 × ULN unless bilirubin increase was due to Gilbert's disease. Further evaluation should be performed to confirm and document the origin of increase. - AST and ALT ≤ 2.5 × institutional upper limit of normal (ULN) - Fasting cholesterol ≤ 300 mg/dL AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication prior initiating study treatment. 8. Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of itacitinib and must agree to use an effective contraception method during the study and for 6 months following the last dose of study drug; females of non-childbearing potential are those who are post-menopausal for more than 1 year or who have had a bilateral tubal ligation or hysterectomy. Female patients undergoing active fertility preservation therapy/egg harvesting which include hCG injections are expected to have mild elevation of hCG. These patients may be allowed to participate in the trial despite elevation of hCG after providing documentation of negative hCG prior the hCG injection and statement from her fertility specialist that they are not pregnant. 9. Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of study drug. 10. Must be able to comply with the study and follow-up requirements. 11. Subject must have access to everolimus via insurance or self-pay. Exclusion Criteria: 1. Unable to sign informed consent form. 2. Pregnant or breast-feeding females (lactating females must agree not to breast feed while taking the investigational agents). 3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. For Example: - symptomatic congestive heart failure of New York Heart Association Class III or IV - unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease - severely impaired lung function as defined as history of DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air - active (acute or chronic) or uncontrolled severe infections - condition requiring ongoing use of medications that are considered STRONG or MODERATE CYP3A4 inhibitors or inducers and P-gp substrates at study screening . However, those who require weak inhibitors/inducers can be enroll at discretion of the PI. - liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C). 4. Bilirubin < 3 × ULN in the presence of liver metastases or presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) 5. Concurrent use of other anti-cancer agents or therapies during study treatment. 6. Use of any other experimental drug or therapy within 28 days of initiating treatment with the investigational agents. 7. Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis C (HCV), or hepatitis B virus (HBV); patients who are seropositive because of hepatitis B virus vaccine are eligible. 8. Previous use of JAK1 inhibitor (itacitinib), or history of progression on everolimus. 9. Has a history of (non-infectious) pneumonitis requiring systemic steroids, or active pneumonitis. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | University of Pennsylvania | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | August 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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