A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)
12 Years
N/A
Both
Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
Trial Information
A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)
Inclusion Criteria:
- Patients with relapsed or refractory systemic ALCL who have previously received front
line chemotherapy.
- Documented anaplastic lymphoma kinase (ALK) status.
- 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 and measurable disease of at least 1.5 cm as documented by
both positron emission tomography and spiral computed tomography.
- Received any previous autologous stem cell transplant at least 12 weeks (3 months)
prior.
- 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.
- Patients with current diagnosis of primary cutaneous ALCL (patients who have
transformed to systemic ALCL are eligible).
- 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
Dana Kennedy, PharmD
Investigator Role:
Study Director
Investigator Affiliation:
Seattle Genetics, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
SG035-0004
NCT ID:
NCT00866047
Start Date:
March 2009
Completion Date:
June 2016
Related Keywords:
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, Non-Hodgkin
- Antigens, CD30
- Antibody-Drug Conjugate
- Antibodies, Monoclonal
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Anaplastic
- monomethyl auristatin E
- Drug Therapy
- Immunotherapy
- Hematologic Diseases
- Lymphoma
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Anaplastic
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 Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
| Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
| Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
| University of Washington | Seattle, Washington 98195 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Oregon Health & Science University | Portland, Oregon 97201 |
| Northwestern University | Chicago, Illinois 60611 |
| Mayo Clinic Rochester | Rochester, Minnesota 55905 |
| Weill Cornell Medical College | New York, New York 10021 |
| Karmanos Cancer Institute / Wayne State University | Detroit, Michigan 48201 |
| Baylor Sammons Cancer Center / Texas Oncology | Dallas, Texas 75246 |
| MD Anderson Cancer Center / University of Texas | Houston, Texas 77030-4003 |
