A prospective phase II study of RICE re-induction, then high-dose fludarabine and busulfan, followed by autologous or allogeneic blood stem cell transplantation for indolent b-cell lymphoma.

Background: Optimal high dose conditioning and relative roles of autologous stem cell transplantation (autoSCT) or allogeneic (alloSCT) for indolent lymphoma are uncertain.

Methods: A prospective phase II study evaluated autoSCT and alloSCT depending on availability of sibling donor after uniform rituximab, ifosfamide, carboplatin, etoposide (RICE) re-induction and novel myeloablative fludarabine, busulfan (FluBu) conditioning for patients with mantle cell lymphoma in first remission or first relapse, or indolent lymphoma in first or second relapse.

Results: The 68 patients (autoSCT, 36; syngeneic [syn], 1; alloSCT, 31) who were accrued had a 10-month median progression-free survival (PFS) after their last chemotherapy treatment. After RICE, the overall response rate was 69%, and 24 of 39 patients (62%) cleared marrow of lymphoma. Treatment-related mortality at 100 days and 1 year after FluBu were both 0% post-auto/synSCT, but were 6% and 26% post-alloSCT, respectively. At a median follow-up of 60 months, the respective 5-year overall survival and PFS rates were 71% and 46% for auto/synSCT, and were 58% and 47% for alloSCT. Quality of life assessment 1-year post-SCT favoured auto/synSCT.

Conclusions: The protocol was feasible, FluBu was well-tolerated, and both auto/synSCT and alloSCT conferred similar 5-year PFS following the RICE-FluBu protocol.