EUCTR2006-005552-33-IT进行中（未招募）不适用
A PHASE Ib/II, OPEN LABEL, MULTICENTER STUDY OF THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF Apo2L/TRAIL ADMINISTERED INTRAVENOUSLY IN COMBINATION WITH RITUXIMAB TO SUBJECTS WITH FOLLICULAR AND OTHER LOW-GRADE, CD20, B CELL NON HODGKIN?S LYMPHOMAS THAT HAVE PROGRESSED FOLLOWING PREVIOUS RITUXIMAB THERAPY - APO3585g
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Subjects must meet the following criteria to be eligible for study entry:
- •Signed Informed Consent Form
- •Age ≥ 18 years
- •Phase Ib Part Only: History of histologically confirmed Stage III or IV CD20+
- •low-grade small lymphocytic lymphoma or marginal zone B-cell lymphoma, or
- •follicular NHL (any grade), according to the World Health Organization (WHO)
- •classification system (Jaffe et al. 2001)
- •Histopathology will be reviewed at the study site to confirm diagnosis,
- •and evaluation of CD20 expression will be based on the standard
- •procedure used at each site.
- •Phase II Part Only: History of histologically confirmed Stage III or IV CD20+
- •follicular NHL Grade 1, 2, or 3a, according to the World Health Organization
- •(WHO) classification system (Jaffe et al. 2001)
- •Histopathology will be reviewed at the study site to confirm diagnosis,
- •and evaluation of CD20 expression will be based on the standard procedure used
- •at each site.
- •Progression of disease following the most recent treatment with
- •rituximab-containing therapy that resulted in stable disease or a partial or
- •complete response lasting ≥ 6 months
- •The rituximab-containing therapy does not have to be the last anti-tumor
- •therapy received. There may have been more than one previous
- •rituximab-containing therapy, but the most recent rituximab-containing
- •Protocol: Apo2L/TRAIL?Genentech, Inc.
- •43/P APO3585g-A3
- •therapy received has to have resulted in stable disease or a response of
- •≥ 6 months duration.
- •Measurable disease (according to modified IWG criteria; see Appendix D)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •(see Appendix F)
- •For subjects of reproductive potential (males and females), use of a reliable means of
- •contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier
- •throughout the trial and for 1 year following their final exposure to study treatment).
- •Life expectancy of > 3 months
- •Willingness and capability to comply with the requirements of the study
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who meet any of the following criteria will be excluded from study entry:
- •Prior radiotherapy to a measurable, metastatic lesion(s) to be used to
- •measure response unless that lesion shows unequivocal progression at baseline
- •Radiation therapy to a peripheral lesion within 14 days prior to Day 1;
- •Radiation therapy to a thoracic, abdominal, or pelvic field within 28 days prior
- •Chemotherapy, hormonal therapy, radiotherapy, or immunotherapy within
- •4 weeks prior to Day 1 (6 weeks for nitrosoureas or mitomycin)
- •Prior radioimmunotherapy, including radio-labeled antibodies
- •Prior treatment with Apo2L/TRAIL or an agonist antibody to DR4 or DR5
- •Concurrent systemic corticosteroid therapy (except low-dose corticosteroid
- •therapy used to treat an illness other than lymphoma)
- •Evidence of clinically detectable ascites on Day 1
- •Other invasive malignancies within 5 years prior to Day 1 (other than basal
- •cell carcinoma of the skin or in situ carcinoma of the cervix)
- •History or evidence upon physical examination of CNS disease (e.g., primary
- •brain tumor, seizures not controlled with standard medical therapy, any brain
- •metastases, or history of stroke) within 1 year prior to study entry
- •Active infection requiring parenteral antibiotics on Day 1
- •Major surgical procedure, open biopsy, or significant traumatic injury within
- •28 days prior to Day 1 or anticipation of need for major surgical procedure
- •during the course of the study and fine needle aspirations within 7 days prior
- •to Day 1Pregnancy or lactation
- •Serious nonhealing wound, ulcer, or bone fracture
- •Current or recent (within the 28 days prior to Day 1) participation in another
- •experimental drug study
- •Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
- •myocardial infarction, unstable angina), New York Heart Association (NYHA)
- •Grade II or greater congestive heart failure (see Appendix B), serious
- •ventricular cardiac arrhythmia requiring medication within 1 year prior to
- •Day 1, Grade II or greater peripheral vascular disease on Day 1
- •(see Appendix G)
- •Clinical laboratory values
- •ANC < 1500/μL
- •Platelet count < 75,000/μL
- •Hemoglobin < 9 g/dL (may not be transfused or treated with erythropoietin
- •to maintain or exceed this level)
- •Total bilirubin > 1.6 mg/dL
- •AST or ALT > 2.5 times the upper limit of normal
- •Serum creatinine > 2.0 mg/dL or measured creatinine clearance
- •< 50 mL/min.
- •Known positive test result for HIV, hepatitis B surface antigen (sAg), hepatitis
- •B IgG or IgM core antibody, or hepatitis C antibody
- •Known sensitivity to murine or human antibodies
- •History of other disease, metabolic dysfunction, physical examination finding,
- •or clinical laboratory finding giving reasonable suspicion of a disease or
- •condition that contraindicates use of an investigational drug or that might
- •affect interpretation of the results of the study or render the subject at high
- •risk from treatment complications
研究者
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