Combined standard graft-versus-host disease (GvHD) prophylaxis with mycophenolate mofetil (MMF) in allogeneic peripheral blood stem cell transplantation from unrelated donors

Bone Marrow Transplant. 2004 Jan;33(1):65-9. doi: 10.1038/sj.bmt.1704299.

Abstract

In this open single-centre phase II study, MMF was added on day +10 after allogeneic transplantation to standard immunosuppressive prophylaxis consisting of cyclosporine and methotrexate to decrease the incidence of GvHD. In all, 30 patients aged 20-59 years with advanced haematological malignancies received an unmanipulated blood-stem-cell graft (median of 8.5 x 10(6) CD34(+) and 349 x 10(6) CD3(+) cells per bodyweight) from matched unrelated (n=26), or mismatched donors (n=4). Prior to transplantation, 13 patients underwent fractionated total body irradiation and cyclophosphamide, one patient additional etoposide. In all, 16 patients received reduced conditioning of fludarabin, busulfan, and antithymocyte globulin. All patients engrafted in a median of 12 days, and 19 developed acute GvHD>/=II, including two patients with GvHD III and three with GvHD IV. Subsequently, nine patients developed limited and two patients extensive chronic GvHD. With a median follow-up of 28 months, the overall survival is 53.3% and disease-free survival 50%, respectively. Only two deaths were due to GvHD IV. Out of 13 patients, 10 being CMV IgG positive became positive for pp65. In conclusion, this MMF schedule seems to be safe and feasible in the prophylaxis of severe acute GvHD for high-risk patients, restricted by an increased risk for reactivating CMV in seropositive patients.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Blood Donors
  • Cyclosporine / administration & dosage
  • Cytomegalovirus / physiology
  • Graft vs Host Disease / mortality
  • Graft vs Host Disease / prevention & control*
  • Hematologic Neoplasms / complications
  • Hematologic Neoplasms / mortality
  • Hematologic Neoplasms / therapy*
  • Humans
  • Methotrexate / administration & dosage
  • Middle Aged
  • Mycophenolic Acid / administration & dosage*
  • Mycophenolic Acid / analogs & derivatives*
  • Peripheral Blood Stem Cell Transplantation / adverse effects
  • Peripheral Blood Stem Cell Transplantation / methods*
  • Peripheral Blood Stem Cell Transplantation / mortality
  • Time Factors
  • Transplantation, Homologous
  • Virus Activation

Substances

  • Cyclosporine
  • Mycophenolic Acid
  • Methotrexate