A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

Seagen

Status and phase

Completed

Phase 2

Conditions

Lymphoma, B-Cell

Lymphoma, T-Cell

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Non-Hodgkin

Treatments

Drug: brentuximab vedotin

Drug: rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01421667

SGN35-012

Details and patient eligibility

About

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).

Enrollment

176 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically-confirmed NHL (DLBCL only for Parts B and C)
Relapsed or refractory disease following at least 1 prior systemic therapy
Measurable disease of at least 1.5 cm as documented by CT
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion criteria

History of another primary invasive malignancy that has not been in remission for at least 3 years
Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
Known cerebral/meningeal disease