Intravenous BU plus Mel: an effective, chemotherapy-only transplant conditioning regimen in patients with ALL

Bone Marrow Transplant. 2013 Jan;48(1):26-31. doi: 10.1038/bmt.2012.114. Epub 2012 Jun 25.

Abstract

We investigated the administration of i.v. BU combined with melphalan (Mel) in patients with ALL undergoing allogeneic hematopoietic SCT. Forty-seven patients with a median age of 33 years (range 20-61) received a matched sibling (n=27) or matched unrelated donor transplant (n=20) for ALL in first CR (n=26), second CR (n=13), or with more advanced disease (n=8). BU was infused daily for 4 days, either at a fixed dose of 130 mg/m² (5 patients) or using pharmacokinetic (PK) dose adjustment (42 patients), to target an average daily area-under-the-curve (AUC) of 5000 μmol/min, determined by a test dose of i.v. BU at 32 mg/m². This was followed by a rest day, then two daily doses of Mel at 70 mg/m². Stem cells were infused on the following day. The 2-year OS, PFS and non-relapse mortality (NRM) rates were 35% (95% confidence interval (CI), 23-51%), 31% (95% CI, 21-48%) and 37% (95% CI, 23-50%), respectively. Acute NRM at 100 days was favorable at 12% (95% CI, 5-24%); however, the 2-year NRM was significantly higher for patients older than 40 years, 58% vs 20%, mainly due to GVHD.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Age Factors
  • Antineoplastic Agents, Alkylating / administration & dosage
  • Antineoplastic Agents, Alkylating / adverse effects
  • Antineoplastic Agents, Alkylating / therapeutic use*
  • Busulfan / administration & dosage
  • Busulfan / adverse effects
  • Busulfan / therapeutic use*
  • Drug Therapy, Combination / adverse effects
  • Female
  • Follow-Up Studies
  • Graft vs Host Disease / epidemiology
  • Graft vs Host Disease / etiology
  • Graft vs Host Disease / prevention & control
  • Hematopoietic Stem Cell Transplantation / adverse effects*
  • Humans
  • Incidence
  • Infusions, Intravenous
  • Male
  • Melphalan / adverse effects
  • Melphalan / therapeutic use*
  • Middle Aged
  • Myeloablative Agonists / administration & dosage
  • Myeloablative Agonists / adverse effects
  • Myeloablative Agonists / therapeutic use*
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / prevention & control
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / therapy*
  • Secondary Prevention
  • Survival Analysis
  • Texas
  • Transplantation Conditioning* / adverse effects
  • Transplantation, Homologous
  • Young Adult

Substances

  • Antineoplastic Agents, Alkylating
  • Myeloablative Agonists
  • Busulfan
  • Melphalan