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临床试验/EUCTR2006-005552-33-FR
EUCTR2006-005552-33-FR进行中（未招募）1 期

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

Genentech Inc.0 个研究点目标入组 120 人开始时间: 2007年4月5日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
120
研究概览入排标准研究者记录与标识符相似试验

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

  • •Signed Informed Consent Form
  • •Age >18 years
  • •History of histologically confirmed stage III or IV CD20+ follicular NHL Grade 1, 2, or 3a, according to the World Health Organization (WHO) classipcation system (Jaffe et al. 2001)
  • •- Histopathology will be reviewed at the study site to conprm 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 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 of the protocol)
  • •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 [IUDJ, physical barrier throughout the trial and for 1 year following their pnal 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

  • •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 to Day 1
  • •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)
  • •Pregnancy 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/uL
  • •- Platelet count <75,000/uL
  • •- 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
  • •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 1

研究者

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