A Phase 2 Study of Brentuximab Vedotin in Combination With Standard of Care Treatment (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [RCHOP]) as Front-line Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

The purpose of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as A+RCHOP) in patients with DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups.

Who is eligible to participate?

Inclusion Criteria: - Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b - International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age - Stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB-IV disease - Measurable disease of at least 1.5 cm - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Exclusion Criteria: - Previous history of treated indolent lymphoma - History of another primary malignancy that has not been in remission for 3 years

Last updated:

9/30/2014

NCT ID:

NCT01925612

IRB Number:

13-003169