Last reviewed · How we verify
A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.
Details
| Lead sponsor | Seagen Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 58 |
| Start date | 2009-03 |
| Completion | 2016-06 |
Conditions
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, Non-Hodgkin
Interventions
- brentuximab vedotin
Primary outcomes
- Objective Response Rate by Independent Review Group — up to 12 months
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.
Countries
United States, Belgium, Canada, France, United Kingdom