Fludarabine and cyclophosphamide with filgrastim support in patients with previously untreated indolent lymphoid malignancies

To evaluate the response rate and potential toxicities, a phase II trial wa s conducted of fludarabine and cyclophosphamide with filgrastim support in patients with previously untreated low grade and select intermediate grade lymphoid malignancies. Symptomatic patients with preserved end organ fu not ion received cyclophosphamide 600 mg/m(2) intravenous (iv) day 1 and fludar abine 20 mg/m(2) iv days1 through 5, followed by filgrastim 5 mu g/kg subcu taneous starting approximately day 8. Treatment was repeated every 28 days until maximum response or a maximum of 6 cycles. Sixty patients, median age 53.5 years, were enrolled. Thirty-seven patients with non-Hodgkin lymphoma (NHL) were stage IV and 6 were stage ill, Eleven of 17 patients with chron ic lymphocytic leukemia (CLL) were Rai intermediate risk end 6 were high ri sk. The overall complete response (CR) rate was 51% and the partial respons e (PR) rate was 41%. Of patients with CLL, 47% achieved a CR and the remain ing 53% achieved a PR. Of patients with follicular lymphoma, 60% achieved C R and 32% achieved a PR. Although the toxicity of this regimen was mainly h ematologic, significant nonhematologic toxicities, including infections, we re seen. Twenty-four patients subsequently received an autologous or alloge neic stem cell transplant. Engraftment was rapid, and there were no noticea ble procedure toxicities in the immediate posttransplant period attributabl e to the fludarabine and cyclophosphamide regimen. Fludarabine, cyclophosph amide, and filgrastim make up a highly active and well-tolerated regimen in CLL and NHL. (Blood. 2000;96:71-75) (C) 2000 by The American Society of He matology.