EUCTR2007-001666-32-ES进行中（未招募）1 期
A PHASE II, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY OF THE SAFETY,PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF APOMAB ADMINISTERED INTRAVENOUSLY IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH FOLLICULAR, CD20-POSITIVE B-CELL NON-HODGKIN’S LYMPHOMA THAT HAS PROGRESSED FOLLOWING PREVIOUS RITUXIMAB THERAPYESTUDIO FASE II, ALEATORIZADO , DOBLE CIEGO, CONTROLADO CON PLACEBO PARA VALORAR LA SEGURIDAD, FARMACOCINÉTICA Y EFICACIA DE MULTIPLES DOSIS DE APOMAB ADMINISTRADAS POR VIA INTRAVENOSA EN COMBINACIÓN CON RITUXIMAB EN PACIENTES CON LINFOMA NON HODGKING FOLICULAR CON CELULAS B CD20 POSITIVAS QUE HAN PROGRESADO DESPUÉS DE UNA TERAPIA PREVIA CON RITUXIMAB
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •>Diagnosis of follicular, CD20-positive B-cell NHL classified as Grade 1, 2, or
- •3a according to the WHO classification of malignant lymphomas
- •>Progression of disease after an objective response (CR/CRu or PR) or SD
- •lasting 6 months following completion of the most recent rituximab-containing regimen
- •>A rituximab-containing regimen is defined as rituximab as a single agent
- •during induction and/or maintenance, or in combination with other agents.
- •>Measurable disease (according to modified IWG Criteria; see Appendix B)
- •ECOG performance status of 0 or 1 (see Appendix D)
- •>Life expectancy of 3 months
- •>Willingness and capability to be accessible for follow-up until study
- •termination or death
- •>For patients of reproductive potential (both males and females), use of a
- •reliable means of contraception (e.g., contraceptive pill, intrauterine device
- •[IUD], barrier methods) throughout the trial and for 1 year following their last
- •exposure to study treatment
- •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
- •>Grade 3b follicular lymphoma (according to the WHO classification) or
- •histologic transformation from follicular lymphoma to aggressive lymphoma
- •>Prior radiotherapy to a lesion(s) that will be used to assess response unless
- •that lesion(s) shows clear evidence of lymphoma progression at baseline
- •(i.e., =50% increase in the product of the longest perpendicular diameters of
- •the lesion [greatest transverse diameter perpendicular diameter] when
- •compared with the nadir of lesion dimensions following radiotherapy and
- •1.5 cm in the greatest transverse diameter)
- •>Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1 or
- •radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to
- •Cycle 1, Day 1
- •>Prior radio-immunotherapy, including radiolabeled antibodies
- •>Concurrent systemic corticosteroid therapy (except low-dose corticosteroid
- •therapy used to treat an illness other than lymphoma)
- •>Other invasive malignancies within 5 years prior to Cycle 1, Day 1 (other than
- •basal or squamous cell carcinoma of the skin or in situ carcinoma of the
- •cervix treated with curative intent)
- •>History or evidence on physical examination of central nervous system
- •(CNS) disease (e.g., primary brain tumor, CNS lymphoma, seizures not
- •controlled with standard medical therapy, any brain metastases, or history
- •>Prior treatment with agonistic DR4 or DR5 antibodies or Apo2L/TRAIL
- •>General Medical Concerns
- •>Current or recent (within the 28 days prior to Cycle 1, Day 1) participation in
- •another experimental drug study
- •>Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
- •myocardial infarction within 1 year prior to Cycle 1, Day 1, unstable angina),
- •New York Heart Association (NYHA; see Appendix E) Grade II or greater
- •congestive heart failure, serious cardiac arrhythmia requiring medication
- •within 1 year prior to Cycle1, Day 1, or Grade II or greater peripheral vascular
- •disease (see Appendix F) at study entry
- •>Active infection requiring parenteral antibiotics on Cycle 1, Day 1
- •Protocol: Apomab—Genentech,
- •>Major surgical procedure (excluding lymph node biopsy) or significant
- •traumatic injury within 28 days prior to Cycle 1, Day 1, or anticipation of need
- •for major surgical procedure during the course of the study
- •>Pregnancy (positive pregnancy test) or breast feeding
- •>Serious, non-healing wound, ulcer, or bone fracture
- •Laboratory values
- •ANC 1500/L (may not be treated with G-CSF to maintain or exceed
- •this level) Platelet count 75,000/L Total bilirubin1.6 mg/dL AST or ALT 2.5 the upper limit of normal (ULN) Serum creatinine 2.0 mg/dL or measured creatinine clearance
- •=50 mL/min Hemoglobin 9 g/dL (may not be transfused or treated with erythropoietin to maintain or exceed this level)
- •>Known human immunodeficiency virus (HIV) infection, seropositivity for
- •hepatitis B surface antigen (HBsAg), hepatitis B IgG or IgM core antibody,
- •or hepatitis C virus (HCV) antibody
- •>History of other disease, metabolic dysfunction, physical finding,
- •or 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 patient at high risk from
- •treatment complications
研究者
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