Millennium Initiates Phase II Trial for Diffuse Large B-Cell Lymphoma
News Oct 26, 2009
The Takeda Oncology Company has announced the initiation of a Phase II clinical trial examining rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) with or without VELCADE (bortezomib) for Injection for patients with a common type of lymphoma.
The study will examine previously untreated patients with a genomically defined subtype of lymphoma called non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma.
The non-GCB genomic profile is an important, independent negative prognostic factor for patients with diffuse large B-cell lymphoma. Prior studies have indicated that patients with non-GCB type tumors do not respond well to R-CHOP therapy, which is the current standard of care in this disease setting. This open-label, randomized trial will evaluate whether the addition of VELCADE to R-CHOP (Vc-R-CHOP) improves progression-free survival in the non-GCB patient population.
“This innovative trial is one of our first studies investigating the potential of VELCADE in a genomically defined group of patients,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “Millennium was founded in genomic research. This study demonstrates how we ve applied genomic knowledge in clinical trial design to enroll patients most likely to benefit from our therapies.”
VELCADE is currently approved for use in patients with multiple myeloma and relapsed mantle cell lymphoma, a sub-type of NHL. VELCADE has been used by more than 100,000 patients in more than 87 countries worldwide.