A Phase 2, Single-arm, Open-label Study of Single-agent Brentuximab Vedotin for Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above
Phase 2
60 Years
N/A
60 Years
N/A
Open (Enrolling)
Both
Hodgkin Disease
Both
Hodgkin Disease
Trial Information
A Phase 2, Single-arm, Open-label Study of Single-agent Brentuximab Vedotin for Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above
Inclusion Criteria:
- Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma
- Ineligible for or have declined initial conventional chemotherapy
- Measurable disease of at least 1.5 cm as documented by radiographic technique
- ECOG performance status less than or equal to 3
Exclusion Criteria:
- Symptomatic neurologic disease compromising instrumental activities of daily living
or requiring medication
- Concurrent use of other investigational agents
- Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not
completed 4 weeks prior to first dose of study drug
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response 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:
SGN35-015
NCT ID:
NCT01716806
Start Date:
October 2012
Completion Date:
June 2016
Related Keywords:
- Hodgkin Disease
- Antibody-Drug Conjugate
- Antibodies, Monoclonal
- Hematologic Diseases
- Hodgkin Disease
- Antigens, CD30
- Lymphoma
- monomethylauristatin E
- Drug Therapy
- Immunotherapy
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| University of Rochester Medical Center | Rochester, New York 14642 |
| Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
| City of Hope | Duarte, California 91010 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
| Columbia University Medical Center | New York, New York 10032 |
| Northwest Cancer Specialists, P.C. | Portland, Oregon 97227 |
| Rocky Mountain Cancer Centers - Aurora | Aurora, Colorado 80012 |
| Nebraska Cancer Specialists | Omaha, Nebraska 68114 |
| Illinois Cancer Specialists | Niles, Illinois 60714 |
| Arizona Oncology Associates, PC - HOPE | Tucson, Arizona 85704 |
| Virginia Commonwealth University Medical Center | Richmond, Virginia 23298 |
| Texas Oncology - Seton Williamson | Round Rock, Texas 78665 |
| Willamette Valley Cancer and Research / USOR | Eugene, Oregon 97401 |
| Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care | Christianburg, Virginia 24073 |
| Providence St Joseph Medical Center | Burbank, California 91505 |
| Georgia Cancer Specialists - Admin Annex | Atlanta, Georgia 30341 |
