A phase-two trial evaluating the synergistic activity and toxicity of fludarabine, cyclophosphamide and dexamethasone (FluCyD) in untreated and pre-treated low-grade lymphoproliferative disorders is presented. Patients were given fludarabine 20 mg/m2 on days 1-5, cyclophosphamide 1000 mg/m2 on day 1, dexamethasone 20 mg on days 1-5, every four weeks for a maximum of six courses in untreated cases, and for four courses in pre-treated cases allocated to high-dose consolidation. One patient refused high dose program for persistent disease, and was treated with rituximab. A total of 29 patients were included. The overall response rate was 89%, with actuarial three-year disease free survival and overall survival 56% and 72%, respectively. Haematological toxicity was limited, and main complications of therapy were infections: one patient died of Jacob-Creutzfeld virus encephalitis after FluCyD and rituximab and three other cases, with concomitant or subsequent autoimmune disease requiring immunosuppression, developed central nervous system infection. Nine patients were scheduled to mobilize progenitor cells with chemotherapy and G-CSF. Only two patients mobilized an adequate amount of CD34+, while in two further cases bone marrow harvest was performed, but the product was considered inadequate in one. One patient died after mobilization chemotherapy, because of haemolytic anaemia complicated with acute renal failure. Despite its effectiveness in indolent lymphoproliferative disorders, the incidence of infections, as well as the impact of fludarabine on subsequent peripheral blood stem cell mobilization, suggest that more careful selection criteria must applied before patients are allocated to this regimen.
|Number of pages||6|
|Publication status||Published - Jul 2004|
- Low grade lymphomas
- Stem cell transplantation
ASJC Scopus subject areas