ORLANDO—Giving rituximab(Drug information on rituximab) (Rituxan) after high-dose chemotherapy/autologous peripheral blood stem cell transplantation for B-cell non-Hodgkin’s lymphoma (NHL) produced better survival and freedom from progression rates than would be expected with a conventional transplant regimen, according to a phase II study reported at the 43rd Annual Meeting of the American Society of Hematology (abstract 3578).
The rationale for the study was the 40% to 60% relapse rate among patients receiving high-dose therapy/stem cell transplant, said Steven M. Horwitz, MD, of Stanford University. Since most B-cell NHL patients express the CD20 antigen, rituximab was considered an excellent candidate for adjuvant therapy in the post-transplant setting.
Study Design
The study involved 35 patients with B-cell NHL undergoing high-dose therapy/transplant. Most patients (25) had diffuse large cell NHL, but 3 had mantle cell lymphoma, 3 had transformation of low-grade lymphoma, and 4 had other B-cell lymphomas.
As a preparative regimen, 32 patients received carmustine(Drug information on carmustine) (BiCNU), cyclophosphamide(Drug information on cyclophosphamide), and etoposide(Drug information on etoposide), and 3 had total-body irradiation. All received a purged stem cell product.
The first four patients received four weekly transfusions of rituximab at a dose of 375 mg/m² starting 40 days after transplant. The other 31 patients received that plus an additional 4-week course of rituximab at 6 months.
Among the 35 patients enrolled, 29 completed all planned therapy. Six patients received less rituximab than planned due to neutropenia, hypotension, disseminated zoster, relapse, or death. At a median follow-up of 18 months, four patients had died and four had relapsed.
