The CUP trial: A randomized study analyzing the efficacy of high dose therapy and purging in low-grade non-Hodgkin's lymphoma (NHL)

Background: The CUP trial was initiated to analyze the value of high-dose t herapy and stern-cell transplantation and purging in patients with relapsed chemosensitive follicular NHL. Patients and methods: After three cycles of chemotherapy responsive patient s were randomized to either three more cycles of the same chemotherapy (C), high-dose therapy followed bq autologous unpurged (U) or purged (P) stem-c ell transplantation. Purging was performed using a cocktail of monoclonals. Pretransplant conditioning consisted of cyclophosphamide (60 mg/kg x 2) an d total body irradiation. Results: Of the 140 patients registered from 26 centers in Europe, 89 fulfi lled the criteria for randomization (C: 24, U: 33 and P: 32). Reasons for f ailure to randomize were: no response (28), persistent marrow infiltration (4), patient refusal (7), other (7), no data (5). With the current follow u p (median 26 months from randomization) 16 (66%) in C are known to have pro gressed or relapsed, in contrast to 13 (39%) of U and 12 (37%) of the P pat ients (P-value 0.002). Overall survival is premature with the current avail able data. Conclusions: Patients in U and P arms had higher progression/relapse-free s urvival rate. There are some suggestions of some improvement in overall sur vival rate.