Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
Phase I trial of interleukin-2 after unmodified HLA-matched sibling bone marrow transplantation for children with acute leukemia.
Blood. 1996 Feb 15;87(4):1249-54. Unique Identifier : AIDSLINE MED/96190038 Robinson N; Sanders JE; Benyunes MC; Beach K; Lindgren C; Thompson JA; Appelbaum FR; Fefer A; Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Abstract:
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.
Keywords: Acute Disease Adjuvants, Immunologic/ADMINISTRATION & DOSAGE Adolescence Antigens, CD56/ANALYSIS *Bone Marrow Transplantation Child Child, Preschool Combined Modality Therapy CD8-Positive T-Lymphocytes/IMMUNOLOGY Dose-Response Relationship, Drug Female Graft vs Host Disease/IMMUNOLOGY Histocompatibility Human HLA Antigens/IMMUNOLOGY Infant Interleukin-2/*ADMINISTRATION & DOSAGE Leukemia, Lymphocytic, Acute/*THERAPY Leukemia, Myeloid/*THERAPY Lymphocyte Subsets/IMMUNOLOGY Male Nuclear Family Support, U.S. Gov't, P.H.S. CLINICAL TRIAL CLINICAL TRIAL, PHASE I JOURNAL ARTICLE 960830
M9681223
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Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
