Abstract
Background: High-dose chemotherapy followed by Autologous SCT (stem cell transplantation) is a treatment of choice for relapsed and refractory lymphoma. Due to cost, toxicity, and shortage of Carmustine, we decided to conduct a phase 2 clinical trial to evaluate the safety and efficacy of Bendamustine instead of Carmustine in a previously used BEAM-like protocol. Materials and Methods:102 patients (median age,37) with Hodgkin(n=54) and non-Hodgkin lymphoma(n=48) were recruited and transplanted in two centers. After stem cell harvesting, a modified BeEAM regimen was administered to all the patients. Overall survival and disease-free survival (DFS) at two years were calculated as the study's primary endpoints. Results: Neutrophil and platelet recovery were observed after a median of 12 and 13 days, and all the patients were engrafted. Fever was observed in 25(24.5%) with only two documented infections. The only grade III toxicities were mucositis (20%) and nausea (15.6%). No transplant-related mortality (TRM) was observed after 100 days. After a median follow-up of 37(range 25-48) months, 68(66.6%) patients were in complete remission while 21 patients were in partial response, and 16 patients (15.6%) developed progressive disease, among which 13 (12.7%) had died. The OS at two years was (89 of 102, 87.3%), and the DFS rate was 68 of 102(66.7%). Conclusion: Our study showed that modified BeEAM is a safe, effective, and feasible conditioning regimen for ASCT in lymphoma instead of the BEAM regimen.