A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Hodgkin Disease
Both
Hodgkin Disease
Trial Information
A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Inclusion Criteria:
- Histopathological diagnosis of classical Hodgkin lymphoma
- Failed standard front-line therapy
- Measurable disease of at least 1.5 cm as documented by radiographic technique
- Eastern Cooperative Oncology Group performance status less than or equal to 2
Exclusion Criteria:
- Received prior salvage therapy, including radiotherapy
- Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not
completed 4 weeks prior to first dose of study drug
- Concurrent use of other investigational agents
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete remission rate
Outcome Time Frame:
Through 1 month following last dose
Safety Issue:
No
Principal Investigator
Megan O'Meara, MD
Investigator Role:
Study Director
Investigator Affiliation:
Seattle Genetics, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
SGN35-016
NCT ID:
NCT01874054
Start Date:
June 2013
Completion Date:
December 2017
Related Keywords:
- Hodgkin Disease
- Antibody-Drug Conjugate
- Antibodies, Monoclonal
- Hodgkin Disease
- Hematologic Diseases
- Drug Therapy
- Immunotherapy
- Antigens, CD30
- Lymphoma
- monomethylauristatin E
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Stanford Cancer Center | Stanford, California 94305-5824 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Pacific Hematology Oncology Associates | San Francisco, California 94115 |
| Columbia University Medical Center | New York, New York 10032 |
| University Hospitals Case Medical Center | Cleveland, Ohio 44106 |
| Saint Francis Hospital | Greenville, South Carolina 29601 |
| Colorado Blood Cancer Institute | Denver, Colorado 80218 |
| Virginia Commonwealth University Medical Center | Richmond, Virginia 23298 |
| Oncology Institute of Hope & Innovation, The | Whittier, California 90603 |
