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Phase I trial of interleukin-2 after unmodified HLA-matched sibling bone
marrow transplantation for children with acute leukemia
N Robinson, JE Sanders, MC Benyunes, K Beach, C Lindgren, JA Thompson, FR Appelbaum and A Fefer
Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Allogeneic bone marrow transplantation (BMT) for advanced acute leukemia is
associated with a high risk of relapse. It is postulated that interleukin-2
(IL-2) administered after BMT might induce or amplify a
graft-versus-leukemia effect and thereby reduce the relapse rate. To
identify an IL-2 regimen for testing this hypothesis, a phase I trial of
IL-2 (Roche) was performed in children in complete remission (CR) without
active graft-versus-host disease (GVHD) off immunosuppressive agents after
unmodified allogeneic matched-sibling BMT for acute leukemia beyond first
remission. Beginning a median of 68 days after BMT, 17 patients received
escalating doses of induction IL-2 (0.9, 3.0, or 6.0 x 10(6) IU/m2/d
representing levels I, II, and III) for 5 days by continuous intravenous
infusion (CIV). After 6 days of rest, they received maintenance IL-2 (0.9 x
10(6) IU/m2/d) for 10 days by CIV infusion. Levels I and II were
well-tolerated, but, of 6 patients at level III, 1 developed pulmonary
infiltrates, 1 developed hypotension (both resolved), and 1 died of
bacterial sepsis and acute respiratory distress syndrome. Grade II acute
GVHD developed in 1 patient at level I and 1 at level III. The maximum
tolerated dose of induction IL-2 was level II. IL-2 induced lymphocytosis,
with an increase in CD56+ and CD8+ cells. Ten patients remain in CR at 5+
to 67+ months. Thus, a regimen of IL-2 has been identified that did not
induce a high incidence of acute GVHD when administered to children after
unmodified allogeneic BMT. Its clinical activity will be assessed in a
phase II trial.
Volume 87,
Issue 4,
pp. 1249-1254,
02/15/1996
Copyright © 1996 by The American Society of Hematology
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