A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma
Phase 1
18 Years
60 Years
18 Years
60 Years
Not Enrolling
Both
Disease, Hodgkin
Both
Disease, Hodgkin
Trial Information
A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma
Inclusion Criteria:
- Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
- Measurable disease of at least 1.5 cm
- Eastern Cooperative Oncology Group performance status <3
Exclusion Criteria:
- History of another primary malignancy that has not been in remission for at least 3
years
- Known cerebral/meningeal disease
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of adverse events and laboratory abnormalities
Outcome Time Frame:
Through 1 month after last dose
Safety Issue:
Yes
Principal Investigator
Naomi Hunder, MD
Investigator Role:
Study Director
Investigator Affiliation:
Seattle Genetics, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
SGN35-009
NCT ID:
NCT01060904
Start Date:
January 2010
Completion Date:
September 2012
Related Keywords:
- Disease, Hodgkin
- Antibodies, Monoclonal
- Antibody-Drug Conjugate
- Antigens, CD30
- Disease, Hodgkin
- Hematologic Diseases
- Immunotherapy
- Lymphoma
- monomethyl auristatin E
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| MD Anderson Cancer Center / University of Texas | Houston, Texas 77030-4003 |
| UNC Lineberger Comprehensive Cancer Center / University of North Carolina | Chapel Hill, North Carolina 27599 |
