A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Seagen Inc.
- Study ID
- NCT01421667
- Phase
- PHASE2
- Status
- Completed
Conditions
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- brentuximab vedotin — DRUG1.8 mg/kg every 3 weeks by IV infusion
- rituximab — DRUG375 mg/m2 every 3 weeks by IV infusion
Study Details
This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).
Key Dates
- Start date
- Aug 31, 2011
- Status verified
- Jun 2015
- Primary completion
- Jun 30, 2015
- Completion
- Jun 30, 2015
Study Design
- Enrollment
- 176 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Brentuximab vedotin+rituximab
- Experimental: Brentuximab vedotin
Primary Outcome Measure
Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy [ Time Frame: Up to approximately 3 years ]
Locations (33)
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