Long-term results of fludarabine/melphalan as a reduced-intensity conditioning regimen in mantle cell lymphoma: the GELTAMO experience

Background: We herein report the long-term results of an allogeneic reduced-intensity conditioning (allo-RIC) protocol used in 21 consecutive patients (16 males, median age 56 years, 71% in complete remission) diagnosed with mantle cell lymphoma (MCL).

Methods: The allo-RIC consisted of fludarabine plus melphalan and peripheral blood hematopoietic stem cells (PBSCs) from human leukocyte antigen (HLA)-identical siblings were used in all cases. Median CD34+ infused cells was 5.8 × 10⁶/kg. All patients engrafted promptly.

Results: Early toxicity included mild/moderate mucositis (43%), febrile neutropenia (33%) and bacterial infections (19%). With a median follow up of 48 months, four deaths were reported, all due to infections and/or graft-versus-host disease (GVHD), yielding a 3-year cumulative incidence of nonrelapse mortality of 19.5%. Grade III–IV acute GVHD occurred in 15% and chronic GVHD in 78%, being extensive in 39%. The 5-year progression-free survival (PFS) and overall survival (OS) were both 80% (95% CI: 63–97%). Age was the only possible prognostic factor for OS, which was 43% for those aged more than 60 years and 100% for those younger (p < 0.001).

Conclusions: Our data confirm that allo-RIC offers a low toxicity profile and a chance for prolonged long-term disease-free survival in MCL, particularly in younger patients.