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, Mark R Litzow, C. Karanes, S. Dahlberg, B. Kirkhart, J. A. Bianco, J. W. Singer

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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
StatePublished - 2000

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lisofylline
Siblings
Randomized Controlled Trials
Bone Marrow
Placebos
Tissue Donors
Bone Marrow Transplantation
Homologous Transplantation
Transplant Recipients
Infection

Keywords

  • Allogeneic bone marrow transplantation
  • Lisofylline

ASJC Scopus subject areas

  • Hematology
  • Transplantation

Cite this

List, A. F., Maziarz, R., Stiff, P., Jansen, J., Liesveld, J., Andrews, F., ... Singer, J. W. (2000). A randomized placebo-controlled trial of lisofylline in HLA-identical, sibling-donor, allogeneic bone marrow transplant recipients. Bone Marrow Transplantation, 25(3), 283-291.

A randomized placebo-controlled trial of lisofylline in HLA-identical, sibling-donor, allogeneic bone marrow transplant recipients. / List, A. F.; Maziarz, R.; Stiff, P.; Jansen, J.; Liesveld, J.; Andrews, F.; Schuster, M.; Wolff, S.; Litzow, Mark R; Karanes, C.; Dahlberg, S.; Kirkhart, B.; Bianco, J. A.; Singer, J. W.

In: Bone Marrow Transplantation, Vol. 25, No. 3, 2000, p. 283-291.

Research output: Contribution to journalArticle

List, AF, Maziarz, R, Stiff, P, Jansen, J, Liesveld, J, Andrews, F, Schuster, M, Wolff, S, Litzow, MR, Karanes, C, Dahlberg, S, Kirkhart, B, Bianco, JA & Singer, JW 2000, 'A randomized placebo-controlled trial of lisofylline in HLA-identical, sibling-donor, allogeneic bone marrow transplant recipients', Bone Marrow Transplantation, vol. 25, no. 3, pp. 283-291.
List, A. F. ; Maziarz, R. ; Stiff, P. ; Jansen, J. ; Liesveld, J. ; Andrews, F. ; Schuster, M. ; Wolff, S. ; Litzow, Mark R ; Karanes, C. ; Dahlberg, S. ; Kirkhart, B. ; Bianco, J. A. ; Singer, J. W. / A randomized placebo-controlled trial of lisofylline in HLA-identical, sibling-donor, allogeneic bone marrow transplant recipients. In: Bone Marrow Transplantation. 2000 ; Vol. 25, No. 3. pp. 283-291.
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