Trial Information

Phase II Study of Rituximab in Combination With Fludarabine and Cyclophosphamide for the Treatment of Relapsed Follicular Lymphoma

The natural history of follicular lymphomas is characterized by a high initial response rate
to chemotherapy followed invariably by relapse, with subsequent remissions of progressively
shorter duration. The majority of patients eventually die of their disease. As yet, there is
no gold standard for the treatment of newly diagnosed or relapsed advanced FL.Rituximab(R)
has been shown to be a highly effective agent in the treatment of FL, either alone or in
combination with chemotherapy. The ability of R to sensitize indolent lymphoma derived cell
lines to cytotoxic chemotherapy agents has been demonstrated. Furthermore, fludarabine (F)
may also sensitize cells to the effects of R. Cyclophosphamide (C) and F have shown in vivo
synergistic activity. In view of the single agent activity and demonstrated synergy between
C and F, and between F and R, we evaluated FC+R in previously treated patients with advanced
FL. The primary aim of this study was to assess the safety profile and clinical activity of
the FC+R combination. The secondary goal was to evaluate the ability of the treatment to
convert bone marrow Bcl2 positivity such that patients achieved molecular remissions.