1. ¹Division of Hematology and Bone Marrow Transplantation, Department of Hematology, Istituto Nazionale per lo Studio e la Cura dei Tumori, University of Milano, Milan, Italy
2. ²Department of Hematology, University of Udine, Udine, Italy
3. ³Department of Medical Statistics, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy
4. ⁴Department of Medical Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori, University of Milano, Milan, Italy
5. ⁵Department of Hematology, Ospedale San Raffaele, Milan, Italy
6. ⁶Department of Bone Marrow Transplantation, Ospedale Cervello, Palermo, Italy
7. ⁷Department of Hematology,University of Modena, Modena, Italy
8. ⁸Department of Hematology, University of Milano Bicocca, Milan, Italy
9. ⁹Department of Hematology, Ospedale San Camillo-Forlanini, Roma, Italy
10. ¹⁰Department of Hematology, Ospedale San Martino, Genova, Italy
11. ¹¹Department of Hematology, Ospedale Riuniti, Bergamo, Italy
12. ¹²Department of Hematology–Oncology, University of Bologna, Bologna, Italy
13. ¹³Department of Hematology, University of Ancona, Ancona, Italy
14. ¹⁴Department of Hematology, University of Torino, Turin, Italy

Correspondence: Professor Dr P Corradini, Division of Hematology and Bone Marrow Transplantation, Department of Hematology, Istituto Nazionale per lo Studio e la Cura dei Tumori, University of Milano, Via Venezian 1, 20133 Milan, Italy. E-mail: paolo.corradini@istitutotumori.mi.it

Received 30 April 2007; Revised 22 May 2007; Accepted 24 May 2007; Published online 28 June 2007.

Abstract

The safety and efficacy of reduced-intensity conditioning (RIC) followed by allogeneic stem cell transplantation (SCT) for relapsed lymphomas remains unresolved. We conducted a prospective, multicentered, phase II trial. A total of 170 relapsed/refractory lymphomas received a RIC regimen followed by SCT from sibling donors. The primary study end point was non-relapse mortality (NRM). Histologies were non-Hodgkin's lymphomas (NHL) (indolent (LG-NHL), n=63; aggressive (HG-NHL), n=61; mantle cell lymphoma (MCL), n=14) and Hodgkin's disease (HD, n=32). Median follow-up was 33 months (range, 12–82). The results show that frequencies were as follows: cumulative NRM at 3 years, 14%; acute and chronic graft-versus-host disease (GVHD) 35 and 52%, respectively; 3-year overall survival (OS), 69% for LG-NHL, 69% for HG-NHL, 45% for MCL and 32% for HD (P=0.058); and 3-year relapse incidence, 29, 31, 35 and 81%, respectively (P<0.001). Relapse risk differed significantly at 3 years between follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL) (14 versus 46%, P=0.04). Molecular remission occurred in 94 and 40% (P=0.002) of patients with FL and CLL, respectively. On multivariate analysis, OS was influenced by chemorefractory disease (hazard ratio (HR)=3.6), diagnosis of HD (HR=3.5), and acute GVHD (HR=5.9). RIC allogeneic SCT is a feasible and effective salvage strategy in both indolent and aggressive NHL