EUCTR2006-004516-51-IT进行中（未招募）不适用
A multicentre open-label, dose-escalation, trial of zanolimumab in combination with CHOP chemotherapy in subjects with CD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvement - Zanolimumab with CHOP in CD4+ non-cutaneous PTCL with nodal involvment
SERONO INTERNATIONAL SA0 个研究点目标入组 24 人开始时间: 2007年5月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
- •1. Non-cutaneous peripheral T-cell lymphoma, with nodal involvement, with a CD4 positive phenotype confirmed by biopsy that must be performed within 2 months of Screening (node involvement must be accessible and measurable) excluding ALK + ALCL 2. Subjects must be eligible for the CHOP chemoterapy regimen. 3. Subjects may have had no more than one previous chemotherapy, excluding anthracyclines, and must have been in remission ofr at least one year. 4. Measurable disease according to the Standardized Response Criteria for NHL 5. Age major/equal 18 years 6. Has read and understands and has signed the informed consent (or has a legally acceptable representative who has signed on theri behalf) 7. Subjects and their partners will be requested to use medically approved contraception (e.g. intra-uterine device, diaphragm, condom with spermicides, contraceptive medication) from signature of informed consent until 8 weeks after the end of the last 3-week Cycle of CHOP. Exception: women who are psotmenopausal for more than 2 years; subjects who are surgically sterile or have a partner who is surgically sterile. 8. ECOG performance status minor/equal 2.
- •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
- •1. Known or suspected hypersensitivity to CHOP or components of the IMP 2. Known infection with HIV, unresolved hepatitis C (HCV RNA + in plasma) or hepatitis B (HBV DNA+, HBs Ag+, HBc Ag+), signs and symptoms of transmissible spongiform encepalopathy 3. Other concurrent or previous malignancies within the past 5 years, except adequately treated in situ carcinoma of the uterine cervix or basal cell carcinoma 4. Significant concurrent, uncontrolled or active medical condition including, but not limited to acute or chronic infectious disease requiring systemic medication renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease. 5. Known or clinical suspicion for CNS involvement of the PTCL with nodal involvement 6. Severe bone marrow impariment as evidenced by Hemoglobin (Hb) < 9.0 g/dL, asbolute neutrophil count (ANC) < 0.5 x 109/l, plateletes < 20 x 109/l at Screening 7. Subjects having received extensive radiotherapy (involving major/equal 30% of bone marrow) within the last 2 years 8. Renal impairment as evidenced by serum creatinine > 1.5 x upper limit of normal (ULN), and/or calculated creatinine clearance < 60 ml/min at Screening. 9. Liver function abnormality as defined by total bilirubin > 1.5 ULN and/or AST/ALT > 2.5 x ULN or for subjects with liver involvement AST/ALT > 5 x ULN 10. INR > 1.5 x ULN at Screening 11. Breast-feeding woment or women with a positive pregnancy test at Screening 12. Any immunosuppressive or cytotoxic drugs within 3 months from Screening (e.g. drugs interfering with the functions of T cell, IL-2, etc) 13. Prior treatment with anti-CD4 monoclonal antibodies within one year prior to Screening
研究者
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