Conditions: Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, T-Cell
Keywords: Lymphoma, Large B-Cell, Diffuse Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Lymphoma, Non-Hodgkin Monomethyl auristatin E Drug Therapy Immunotherapy Hematologic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, T-Cell
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 176
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: brentuximab vedotin intervention 2: rituximab
Intervention descriptions: intervention 1: 1.8 mg/kg every 3 weeks by IV infusion intervention 2: 375 mg/m2 every 3 weeks by IV infusion

Protocol document: