Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
Phase 1
Completed
- Conditions
- Hodgkin's Lymphomas
- Registration Number
- NCT00634452
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
- Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
- Bi-measurable disease
- ECOG Performance Status of 0 - 2
- Meet all screening laboratory values
Exclusion Criteria
- Previous treatment with any other anti-CD30 antibody
- History of allogeneic transplant
- Any tumor lesion greater than or equal to 10 cm in diameter
- Any active or chronic significant infection
- Underlying medical condition which will make the administration of MDX- 1401 hazardous
- Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety and Tolerability Profile Two years
- Secondary Outcome Measures
Name Time Method Tumor response assessment Two year Objective Response Rate (ORR) Day 50
Trial Locations
- Locations (6)
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
ClinWorks Cancer Research Center
🇺🇸Charlotte, North Carolina, United States
Scott and White Memorial Hospital and Clinic
🇺🇸Temple, Texas, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Winship Cancer Institute, Emory University🇺🇸Atlanta, Georgia, United States