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 mu g/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 mu g/kg/d by continuous i.v. infusion for 7 d and then by s.c. administration for 21 d or until platelet (50 x 10(9)/l) and neutrophil (0.5x10(9)/l) recovery had occurred. Treatment was completed in 54% of the patients in the rhIL-3 group versus 75% in the placebo group (

Randomized trial of recombinant human interleukin-3 versus placebo in prevention of bone marrow depression during first-line chemotherapy for ovarian carcinoma

Purpose: To determine whether recombinant human interleukin-3 (rhIL-3) reduces bone marrow depression and improves chemotherapeutic schedule adherence in ovarian cancer patients receiving first-line combination chemotherapy. Patients and Methods: In a randomized multicenter study, 185 patients received carboplatin (dose based on projected area under the concentration-time curve [AUC] = 4) and cyclophosphamide (750 mg/m(2)) day 1, every 3 weeks for six cycles. Patients were randomized to receive rhIL-3 (5 mu g/kg) or placebo once daily subcutaneously on days 3 to 12. Results: Adherence to chemotherapeutic regimen, mean chemotherapy cycle length, tumor response rate, and median survival at 24 months did not differ between groups. The number of side effects-primarily allergic reactions, flu-like symptoms and fever-were higher in the rhIL-3 group, which resulted in 21 discontinuations compared with one in the placebo group. Compared with placebo, the rhIL-3 group had higher patients with World Health Organization (WHO) grade IV thrombocytopenia or number of platelet transfusions did not differ. Leukocyte counts differed only in cycles 1 and 2 between groups, The leukocyte nadir occurred earlier in the rhIL-3 (day 12) than in the placebo group (day 15, P = .006). Leukocytes and neutrophils were only higher in the rhIL-3 group day 1 of cycle 2. In cycles 4 and 5, more patients with WHO grade IV neutropenia received rhIL-3 (P <.005). Eosinophil counts were higher day 1 of cycles 2 to 6 in the rhIL-3 group (P <.0001). Conclusion: rhIL-3 had stimulatory hematopoietic effects. This did not result either in reduction of platelet transfusions or in improvement of chemotherapeutic schedule adherence. There were more side effects in the rhIL-3 group than in the placebo group. rhIL-3 at 5 mu g/kg/d is, therefore, not of clinical benefit in this chemotherapeutic regimen. (C) 1998 by American Society of Clinical Oncology