Status:
COMPLETED
Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hodgkin's Lymphomas
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00634452
Start Date
February 1 2008
End Date
January 1 2010
Last Update
December 6 2012
Active Locations (6)
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1
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
4
ClinWorks Cancer Research Center
Charlotte, North Carolina, United States, 28207