Phase III efficacy study of interleukin-3 after autologous bone marrow transplantation in patients with malignant lymphoma.
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 microgram/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 microgram/kg/d by continuous i.v. infusion for 7 d and then by s.c. administration for 21 d or until platelet (50 x 109/l) and neutrophil (0.5 x 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 x 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 x 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.
Brouwer
R E
RE
Department of Haematology, Leiden University Medical Center, The Netherlands.
Vellenga
E
E
Zwinderman
K H
KH
Bezwoda
W R
WR
Durrant
S T
ST
Herrmann
R P
RP
Kiese
B
B
Maraninchi
D
D
Milligan
D W
DW
Sklenar
I
I
Tabilio
A
A
Volonte
J L
JL
Winfield
D A
DA
Fibbe
W E
WE
D016026:Bone Marrow Transplantation / Q000379:methods*; D005260:Female; D005334:Fever / Q000209:etiology; D006085:Graft Survival; D006801:Humans; D007239:Infections / Q000209:etiology; D007377:Interleukin-3 / Q000627:therapeutic use*; D008297:Male; D009101:Multiple Myeloma / Q000628:therapy*; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D007377:Interleukin-3