A randomized placebo-controlled trial of lisofylline in HLA-identical, sibling-donor, allogeneic bone marrow transplant recipients

A. F. List, R. Maziarz, P. Stiff, J. Jansen, J. Liesveld, F. Andrews, M. Schuster, S. Wolff, M. Litzow, C. Karanes, S. Dahlberg, B. Kirkhart, J. A. Bianco, J. W. Singer

Research output: Contribution to journalArticlepeer-review

22 Scopus citations

Abstract

The purpose of the study was to evaluate the effect of lisofylline (LSF) on engraftment, regimen-related toxicities (RRT), and mortality in patients undergoing allogeneic bone marrow transplantation (BMT). We performed a multicenter, randomized placebo-controlled trial in 60 patients with hematologic malignancies receiving BMT from HLA-identical sibling donors. Patients were randomized to receive either placebo, 2 mg/kg LSF or 3 mg/kg LSF every 6 h, beginning before conditioning and continuing to day 21 or hospital discharge. Treatment groups were balanced with respect to conditioning regimen and disease stage. However, significantly more patients in the 2 mg/kg LSF group were at high risk for RRT due to performance status ≥ 1, age ≥ 40 years, and prior exposure to CMV. Nausea and vomiting were the only adverse events observed in a higher proportion of LSF-treated patients that led to study withdrawal in six of 42 patients (14%). The times to neutrophil recovery to ≥ 500/μl and platelet recovery (> 20,000/μl) were not improved by LSF treatment. Nevertheless, no patient who received treatment with 3 mg/kg LSF developed a documented infection between day 0 and 35 or had a serious or fatal infection between day 0 and 100 (P = 0.003 vs placebo for both). The day-100 survival rate was also significantly improved in the 3 mg/kg LSF group (89%), compared with either the 2 mg/kg LSF (48%) or placebo (61%) groups (log-rank test, 3 mg/kg LSF vs placebo, P = 0.026). We conclude that treatment with LSF 3 mg/kg reduced the incidence of infections and improved 100-day survival in patients receiving related-donor allogeneic bone marrow transplantation.

Original languageEnglish (US)
Pages (from-to)283-291
Number of pages9
JournalBone Marrow Transplantation
Volume25
Issue number3
DOIs
StatePublished - 2000

Keywords

  • Allogeneic bone marrow transplantation
  • Lisofylline

ASJC Scopus subject areas

  • Hematology
  • Transplantation

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