EUCTR2012-004097-26-BE进行中（未招募）1 期
An Open-label, Multicenter, Single-arm, Phase 2 Study of PCI-32765 (ibrutinib) in Subjects with Refractory Follicular Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologic proof of Grade 1, 2, or 3a follicular lymphoma (FL) without clinical or pathological evidence of transformation
- •Previously treated with at least 2 prior lines of therapy, including at least 1 rituximab combination chemotherapy regimen; last prior line of therapy includes an anti CD20 monoclonal antibody-containing chemotherapy regimen (separate lines of therapy are defined as different regimens that are either separated by disease progression, refractory disease, or relapsed disease)
- •Resistant disease to the last therapy, defined as progression of disease during or within 12 months of the last dose of chemotherapy in a CD20 antibody combination chemotherapy regimen
- •At least 1 measurable site of disease according to International Working Group Revised Response Criteria for Malignant Lymphoma
- •Eastern Cooperative Oncology Group performance status grade 0 or 1
- •Hematology and biochemical laboratory values must be within protocol-defined parameters within 7 days prior to enrollment
- •Agrees to protocol-defined use of effective contraception
- •Women of childbearing potential must have a negative serum or urine pregnancy test at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug
- •Prior treatment with PCI-32765 or other Bruton's tyrosine kinase
- •inhibitors (patients who progressed or became refractory while on
- •treatment with P13K inhibitors are excluded)
- •Concurrent enrollment in another therapeutic investigational clinical treatment study
- •Received a prior allogeneic hematopoietic stem cell transplant (prior autologous hematopoietic stem cell transplant is allowed)
- •Known central nervous system lymphoma
- •History of prior malignancy (except malignancy treated with curative intent and with no known active disease present for >=3 years before enrollment, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, or adequately treated cervical carcinoma in situ without evidence of disease)
- •History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- •Requires anticoagulation with warfarin or equivalent vitamin K antagonists
- •Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors
- •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 Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
- •Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C or active infection with Hepatitis B or any uncontrolled active systemic infection requiring intravenous antibiotics
- •Women who are pregnant or breastfeeding
- •Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the patient’s safety, interfere with the absorption or metabolism of PCI-32765 capsules, or put the study outcomes at undue risk
研究者
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