Clinical effect of reduced-intensity conditioning regimen containing antithymocyte globulin for hematopoietic cell transplantation from unrelated-donors

Am J Hematol. 2011 May;86(5):399-405. doi: 10.1002/ajh.21989.

Abstract

The impact of reduced-intensity conditioning (RIC) on the outcomes of hematopoietic cell transplantation (HCT) from unrelated -donors (UD) remains to be determined. We therefore assessed 128 patients, aged 16 to 66 years, with acute leukemia (n = 105) or myelodysplastic syndrome (n = 23) in a UD-HCT trial using RIC with busulfan, fludarabine, and antithymocyte globulin. Patients were transplanted with unmanipulated bone marrow (BM, n = 41) or mobilized peripheral blood mononuclear cells (M-PB, n = 87) and received cyclosporine and methotrexate for graft-versus-host disease (GVHD) prophylaxis. After a median follow-up of 26.7 months (range, 5.9-70.7 months) in surviving patients, 19 patients had died without progression/recurrence of underlying disease, giving a cumulative incidence of transplantation-related mortality (TRM) of 17% (95% confidence interval, 11%-27%; 1-year TRM, 14%). Graft failure (n = 7) and infections (n = 5) were the most common causes of TRM. Only three patients died due to GVHD (acute, one; chronic, two). Graft failure, which occurred in eight patients, showed a significant correlation with graft source (BM, 6/41 vs. M-PB, 2/87; P = 0.009). Donor-patient HLA-disparity did not correlate with GVHD, 1-year TRM, and graft failure. RIC containing antithymocyte globulin led to decreased GVHD-associated, as well as overall, TRM after UD-HCT.

Trial registration: ClinicalTrials.gov NCT00627666.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Antilymphocyte Serum / therapeutic use*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / therapeutic use
  • Bone Marrow Transplantation / adverse effects
  • Bone Marrow Transplantation / mortality
  • Busulfan / administration & dosage
  • Busulfan / therapeutic use
  • Graft Survival / drug effects
  • Graft vs Host Disease / prevention & control
  • Hematopoietic Stem Cell Transplantation / adverse effects
  • Hematopoietic Stem Cell Transplantation / mortality*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Leukemia, Myeloid, Acute / therapy
  • Medical Records
  • Middle Aged
  • Myelodysplastic Syndromes / therapy
  • Peripheral Blood Stem Cell Transplantation / adverse effects
  • Peripheral Blood Stem Cell Transplantation / mortality
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / therapy
  • Retrospective Studies
  • Survival Analysis
  • Transplantation Conditioning / methods*
  • Vidarabine / analogs & derivatives
  • Vidarabine / therapeutic use
  • Young Adult

Substances

  • Antilymphocyte Serum
  • Antineoplastic Agents
  • Immunosuppressive Agents
  • Vidarabine
  • Busulfan
  • fludarabine

Associated data

  • ClinicalTrials.gov/NCT00627666