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

Phase 1

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

• Registration Number: EUCTR2004-004604-20-GB
• Lead Sponsor: Medarex, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-25
• Study Completion: 2008-06-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To measure best objective response rate up to Day 106 in patients with relapsed or refractory Hodgkin's disease administered MDX-060;<br> Secondary Objective: 1. To characterize progressin-free survival<br> 2. To characterize time to progression<br> 3. To determine response duration<br> 4. To determine the immunogenicity of MDX-060<br> 5. To explore the correlation of PET scan results with objective responses observed with conventional imaging in this patient population<br> 6. To characterize the health-related QoL in patients who received MDX-060<br> 7. To characterize the safety of MDX-060<br> ;Primary end point(s): Best objective response rate up to Day 106 (or any prior timepoint during the study if adequate information is available to make the determination) as determined by the Response Criteria for Non-Hodgkin's Lymphoma.