A Phase 2 interventional study of rituximab and rituximab,fludarabine, cyclophosphamide in Follicular Lymphoma, sponsored by Gruppo Italiano Studio Linfomi. Completed at 9 sites in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2006-10-26.
Sponsored by Gruppo Italiano Studio Linfomi · Phase 2, Interventional, and Treatment
Purpose of this study was to assess the safety profile and the anti-lymphoma activity of the FC+R combination.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 54 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Gruppo Italiano Studio Linfomi is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Toxicity during the treatment period
Efficacy evaluated in terms of complete and partial response 1 month after the end of therapy
Efficacy evaluated in terms of molecular response ( bone marrow Bcl2 negativity after treatment)
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Gruppo Italiano Studio Linfomi