Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
histologically documented WHO grade 1-2 ,CD20+,follicular lymphoma
relapsed Follicular lymphoma
stage III or IV disease
Stage II patients are eligible if they present with B symptoms or bulky disease
to have a need for therapy in the opinion of treating clinician
expected survival of 6 months or more
age 18 to 70 years
to have undergone < 3 lines of chemotherapy
performance status of 0 to 2
known HIV infections
Known Hepatitis B or C
previous malignancies, or cardiac, renal, hepatic, or respiratory failure
Pregnant or lactating women and patients of child bearing potential unless using birth control measures
Sacchi S., Tucci A, Merli F, Orsucci L, Cervetti G, Occhini U, Liberati M, Tarantini G, Callea V, Brugiatelli M, Lauta VM, Baldini L, Luminari S, Federico M. Dipartimento di Oncologia ed Ematologia,. Phase II Study with Fludarabine and Cyclophosphamide Plus Rituximab (FC+R) in Relapsed Follicular Lymphoma Patients. ASH 2002. Blood 99, 2002 Ab n° 530