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 therapy and stem-cell transplantation and purging in patients with relapsed chemosensitive follicular NHL. PATIENTS AND METHODS: After three cycles of chemotherapy responsive patients were randomized to either three more cycles of the same chemotherapy (C), high-dose therapy followed by autologous unpurged (U) or purged (P) stem-cell transplantation. Purging was performed using a cocktail of monoclonals. Pretransplant conditioning consisted of cyclophosphamide (60 mg/kg x 2) and total body irradiation.
RESULTS: Of the 140 patients registered from 26 centers in Europe, 89 fulfilled the criteria for randomization (C: 24, U: 33 and P: 32). Reasons for failure to randomize were: no response (28), persistent marrow infiltration (4), patient refusal (7), other (7), no data (5). With the current follow up (median 26 months from randomization) 16 (66%) in C are known to have progressed or relapsed, in contrast to 13 (39%) of U and 12 (37%) of the P patients (P-value 0.002). Overall survival is premature with the current available data.
CONCLUSIONS: Patients in U and P arms had higher progression/relapse-free survival rate. There are some suggestions of some improvement in overall survival rate.

RCT Entities:   Population Interventions Outcomes