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

• Conditions: Relapsed or Refractory Hodgkin’s Disease; MedDRA version: 5.0Level: LLTClassification code 10020266

• Registration Number: EUCTR2004-005040-27-DE
• Lead Sponsor: Bristol-Myers Squibb Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-02
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified