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A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.
Details
| Lead sponsor | Seagen Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 102 |
| Start date | 2009-02 |
| Completion | 2015-05 |
Conditions
- Disease, 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, Italy