A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
12 Years
N/A
Both
Disease, Hodgkin
Trial Information
A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Inclusion Criteria:
- Patients with relapsed or refractory Hodgkin lymphoma who have previously received
autologous stem cell transplant.
- Histologically confirmed CD30-positive disease; tissue from the most recent post
diagnostic biopsy of relapsed/refractory disease must be available for confirmation
of CD30 expression via slides or tumor block.
- Fluorodeoxyglucose-avid disease by positron emission tomography and measurable
disease of at least 1.5 cm as documented by spiral computed tomography.
- At US sites patients greater than or equal to 12 years of age may be enrolled. At
non-US sites patients must be greater than or equal to 18 years of age.
Exclusion Criteria:
- Previous treatment with brentuximab vedotin.
- Previously received an allogeneic transplant.
- Congestive heart failure, Class III or IV, by the New York Heart Association
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/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective Response Rate by Independent Review Group
Outcome Description:
Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Outcome Time Frame:
up to 12 months
Safety Issue:
No
Principal Investigator
Eric Sievers, MD
Investigator Role:
Study Director
Investigator Affiliation:
Seattle Genetics, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
SG035-0003
NCT ID:
NCT00848926
Start Date:
February 2009
Completion Date:
August 2015
Related Keywords:
- Disease, Hodgkin
- Antigens, CD30
- Antibody-Drug Conjugate
- Antibodies, Monoclonal
- Disease, Hodgkin
- Hematologic Diseases
- Lymphoma
- monomethylauristatin E
- Drug Therapy
- Immunotherapy
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Stanford University Medical Center | Stanford, California 94305-5408 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| University of Rochester Medical Center | Rochester, New York 14642 |
| Rocky Mountain Cancer Center | Denver, Colorado 80218 |
| City of Hope National Medical Center | Los Angeles, California 91010 |
| University of Washington | Seattle, Washington 98195 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Oregon Health & Science University | Portland, Oregon 97201 |
| Georgetown University | Washington, District of Columbia 20007-2197 |
| Ohio State University | Columbus, Ohio 43210 |
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
| University of Miami | Miami, Florida 33136 |
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Mayo Clinic Rochester | Rochester, Minnesota 55905 |
| University of California at Los Angeles | Los Angeles, California 90095 |
| Weill Cornell Medical College | New York, New York 10021 |
| Baylor Sammons Cancer Center | Dallas, Texas 75246 |
| Loyola University Medical Center Cardinal Bernardin Cancer Center | Maywood, Illinois 60153 |
