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48 Chapter 1: AML<br />

Several centers have explored the use of IL-2 either as part of a <strong>marrow</strong> purging<br />

approach with in vitro incubation of the graft with IL-2, concomitant with administration<br />

of IL-2 in the early posttransplant phase, or as consolidation therapy<br />

following hematologic recovery. 1213<br />

Robinson et al. reported on 22 patients with<br />

acute leukemia in relapse or beyond first remission who underwent <strong>autologous</strong><br />

BMT or peripheral <strong>blood</strong> stem cell transplant using cells that were harvested during<br />

first complete remission. 14<br />

IL-2 was given by continuous intravenous infusion after<br />

hematologic recovery at doses ranging from 9 to 12 million IU/m 2<br />

/d for 4-5 days<br />

followed 1 week later by a 10-day infusion of 1.6 million IU/m 2<br />

/d. Among 17<br />

patients with AML, four remained in continuous remission from 12 to 25 months<br />

after therapy <strong>and</strong> four of five ALL patients were also in remission 15-25 months<br />

after therapy. This regimen is currently undergoing evaluation in a r<strong>and</strong>omized<br />

study at the Southwest Oncology Group in which patients with lymphoma<br />

undergoing a peripheral <strong>blood</strong> stem cell transplant are r<strong>and</strong>omized to receive a<br />

single course of IL-2 vs. no therapy.<br />

Based on the laboratory studies indicating induction of effector cells that have<br />

the capacity for lysing <strong>autologous</strong> tumor cells <strong>and</strong> the clinical trials indicating a<br />

potential therapeutic effect in patients undergoing <strong>autologous</strong> transplant for<br />

relapsed disease, we have explored the feasibility of administering posttransplant<br />

IL-2 in patients undergoing <strong>autologous</strong> transplant following high dose Ara-C<br />

consolidation <strong>and</strong> mobilization of stem cells <strong>and</strong> who were then treated with a<br />

radiation-based transplant regimen. The goals of this study were to determine the<br />

feasibility, toxicity, <strong>and</strong> therapeutic effect of a treatment program that began with<br />

consolidation therapy of AML in first remission.<br />

MATERIALS AND METHODS<br />

Patient population<br />

Between August 1994 <strong>and</strong> April 1998, 54 patients with AML in first remission<br />

were entered onto the study. The median age of this adult population was 46<br />

(21-60). Cytogenetic analysis of the leukemia at diagnosis included favorable<br />

T8;21, inversion 16=13 (24%), intermediate (normal) = 23 (43%), unfavorable 7<br />

(13%), <strong>and</strong> indeterminate <strong>and</strong> unknown 11 (20%). The median time from<br />

achievement of complete remission to entry on study was 27 days (7-327).<br />

Treatment program<br />

Patients with AML in first complete remission were treated with consolidation<br />

therapy using a regimen of high-dose Ara-C with or without idarubicin. Ara-C was<br />

given at 3 g/m 2<br />

over 3 hours for eight doses, <strong>and</strong> idarubicin was given at 12 mg/m 2

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