An Open-Label, Phase II Extension Study of MDX-060 in Patients with Relapsed or Refractory Hodgkin’s Disease Treated in Protocol MDX060-03 - not available

Bristol-Myers Squibb Company0 个研究点目标入组 84 人开始时间: 2005年3月2日最近更新: 2013年2月11日

适应症

试验速览

暂无简介。

•1. Experienced disease relapse or progression in Protocol MDX060-03;
•2. Life expectancy =12 weeks;
•3. Laboratory values must meet the following criteria:
•WBC = 1500/µL
•Neutrophils = 1000/µL
•Platelets = 75,000/µL
•Hemoglobin = 8 g/dL
•Creatinine = 2 ULN
•AST = 2 ULN
•Serum total bilirubin = 2 mg/dL (unless diagnosed with Gilbert’s syndrome)
•Laboratory abnormalities outside of the permissible range, but attributed to lymphoma, with clear involvement of the related organ, will be permitted;
•4. Patient must have read and understood and provided written informed consent after the nature of the study has been fully explained;
•5. Women of childbearing potential must have a negative serum ß-HCG pregnancy test conducted during the pretreatment period (within 7 days of IMP administration) and a negative urine ß-HCG pregnancy test conducted immediately prior to the first and fourth administrations of IMP at each cycle;
•6. Men who may father a child must agree to the use of male contraception for the duration of their participation in the study; and
•7. Patients on corticosteroids must be tapered offf the medication 2 weeks prior to MDX-060 administration and remain off corticosteroids 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

•1. Adverse event attributed to MDX-060 necessitating discontinuation of MDX-060;
•2. Active significant infection;
•3. 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 re-treatment). Patients with a positive PPD who have received prophylaxis will be permitted re-treatment;
•4. Pregnant or nursing;
•5. Any underlying condition which in the Investigator’s opinion will make the administration of IMP hazardous or obscure the interpretation of adverse events;or
•6. Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy.

发起方