Phase III efficacy study of interleukin‐3 after autologous bone marrow transplantation in patients with malignant lymphoma

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Abstract
We evaluated the efficacy of recombinant human interleukin‐3 (rhIL‐3) in reducing the number of platelet transfusions and major infections after autologous bone marrow transplantation (ABMT) in patients with malignant lymphoma. 198 patients with non‐Hodgkin's lymphoma (NHL, n = 111) and Hodgkin's disease (HD, n = 87) were randomized to receive rhIL‐3 10 μg/kg/d (n = 130) or placebo (n = 68) for a maximum of 28 d after ABMT. Several well‐known conditioning regimens were used. From day 1 after ABMT patients were treated with placebo or rhIL‐3 at a dose of 10 μg/kg/d by continuous i.v. infusion for 7 d and then by s.c. administration for 21 d or until platelet (50 × 109/l) and neutrophil (0.5 × 109/l) recovery had occurred. Treatment was completed in 54% of the patients in the rhIL‐3 group versus 75% in the placebo group (P < 0.004). Adverse events were the main reason for premature discontinuation in the IL‐3 group (23% IL‐3 v 5% placebo). The median number of platelet transfusions was not significantly different between the IL‐3 group and the placebo group (8.0 IL‐3 v 6.0 placebo, P = 0.09). Platelet engraftment ( 20 × 109/l) was not significantly faster in the IL‐3 group (28 d in the IL‐3 and 27 d in the placebo group, P = 0.06) and the incidence of haemorrhagic complications was similar in both groups. In patients receiving the full intended dose of rhIL‐3, platelet engraftment to 20 × 109/l was delayed (P = 0.007). The median time to neutrophil engraftment was 23 d in the IL‐3 and 25 d for the placebo group (P = 0.39). There was no difference in the incidence of major infections. We conclude that treatment with IL‐3 has no clinical benefit in patients receiving ABMT for malignant lymphoma.

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