EUCTR2004-004604-20-GB进行中（未招募）1 期
An Open-Label, Two-Stage, Fixed-Dose, Multicenter Phase II Study of MDX-060 in Patients with Relapsed or Refractory Hodgkin’s Disease - not available
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
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
入选标准
- •1. Diagnosis of HD (excluding HIV-associated HD);
- •2. Patients must have failed or relapsed second line (i.e., salvage) chemotherapy or relapsed or failed autologous stem cell transplant. Patients who are not candidates for stem cell transplant, exhibit chemo-resistant disease, or refuse further chemotherapy may also be included;
- •3. Patients must have measurable disease;
- •4. At least 4 weeks since the last chemotherapy or radiation prior to the first dosing of MDX-060 and have recovered from any toxicity associated with such treatment or returned to baseline;
- •5. Age = 18 years;
- •6. Life expectancy =12 weeks;
- •7. ECOG Performance Status of 0 – 2 (Appendix 2);
- •8. Screening laboratory values must meet the following criteria:
- •WBC = 1500/µL
- •Neutrophils = 1000/µL
- •Platelets = 75,000/µL
- •Hemoglobin = 8.0 g/dL
- •Creatinine = 2 ULN
- •AST = 2 ULN
- •Serum total bilirubin = 2 mg/dL (unless diagnosed with Gilbert’s syndrome)
- •HIV negative
- •Hepatitis B surface antigen negative for active or chronic infection
- •Hepatitis C antibody negative for active or chronic infection
- •Laboratory abnormalities outside of the permissible range, but attributed to lymphoma, with clear involvement of the related organ, will be permitted;
- •9. Patient must have read, understood, and provided written informed consent after the nature of the study has been fully explained;
- •10. Women must meet 1 of the following criteria: post-menopausal for at least 1 year; surgically incapable of bearing children; or utilizing a reliable form of contraception. Women of childbearing potential must have a negative serum ß-HCG pregnancy test conducted during screening (within 7 days of IMP administration); and
- •11. Men who may father a child must agree to the use of male contraception for the duration of their participation in the study.
- •12. Patients on corticosteriods must be tapered off the medication 2 weeks prior to MDX-060 administration and remain off corticosteriods until Day 106
- •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. Previous treatment with any anti-CD30 antibody;
- •2. History of allogenic transplantation;
- •3. Any tumor lesion = 10 cm in diameter;
- •4. Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease-free for at least 5 years is permissible;
- •5. Any significant active or chronic infection;
- •6. Apparent active or latent infection, as indicated by any of the following: purified protein derivative (PPD) recently converted to positive; chest X-ray with evidence of infectious infiltrate; recent changes in fever/chill patterns (patients with a positive PPD who have a history of BCG vaccination, chest X-ray without evidence of tuberculosis, and no signs or symptoms of tuberculosis, will be permitted to be enrolled in the study). Patients with a positive PPD who have received prophylaxis will be admitted into the study;
- •7. Pregnant or nursing;
- •8. Any underlying medical condition which, in the Principal Investigator’s opinion, will make the administration of IMP hazardous or obscure the interpretation of adverse events; or
- •9. Concomitant chemotherapy, systemic steroids, investigational agents, other anti-HD biologics, or radiation therapy.
研究者
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