Hodgkin's Lymphomas Clinical Trial
— MDX1401-01Official title:
A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
| Verified date | December 2012 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Winship Cancer Institute, Emory University | Atlanta | Georgia |
| United States | ClinWorks Cancer Research Center | Charlotte | North Carolina |
| United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
| United States | West Virginia University | Morgantown | West Virginia |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Scott and White Memorial Hospital and Clinic | Temple | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and Tolerability Profile | Two years | Yes | |
| Secondary | Objective Response Rate (ORR) | Day 50 | No | |
| Secondary | Tumor response assessment | Two year | No |