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Purpose: This phase I infusion rate escalation trial was undertaken to evaluate the maximum applicable infusion rate for rituximab without steroid premedication in patients having received one previous rituximab infusion. Experimental Design: Cohorts of at least three patients were assigned to rituximab with or without concomitant chemotherapy. The initial infusion rate was 200 mg/h in the first cohort, and was increased by 100 mg/h in each subsequent cohort to a maximum of 700 mg/h. In each patient the infusion rate was increased by 100 mg/h every 30 minutes to the total dose (375 mg/m 2 ). In the first six cohorts (21 patients), two well-tolerated rituximab administrations were required; in the 7th cohort (11 patients) one previously well-tolerated rituximab infusion was required. Patients did not receive steroid premedication and were monitored with electrocardiograms (ECG), echocardiograms, Holter ECGs, troponin, and brain natriuretic peptide (BNP). Results: Thirty-two patients were included and 128 cycles were done, 85 at a rate of 700 mg/h. Patients tolerated infusion rates without major side effects. There were no new clinically relevant ECG alterations. Troponin (< 0.1ng/L) and mean cardiac ejection fraction (65%) remained in the reference range; BNP baseline level increased significantly 24 hours after rituximab administration (from 30.4 to 64.1ng/L; P < 0.0001).Conclusions: Rituximab can be administered safely at 700 mg/h without steroid premedication in patients having received at least one rituximab dose in the previous 3 months.Rituximab is a monoclonal antibody against the lymphocyte surface antigen CD20. First introduced in 1995 for the treatment of non -Hodgkin's B-lymphoma, rituximab has today a broad spectrum of indications, including treatment of rheumatoid arthritis, thrombotic thrombocytopenic purpura, and systemic lupus erythematosis, among many others (1 -6). Treatment with rituximab is generally well tolerated and can be combined with chemotherapy, improving response rate, response duration, and in some cases overall survival of patients with B-cell lymphomas (1). Infusion-related reactions can occur in approximately one fourth of patients during the first administration, probably due to a release of cytokines into the blood as a consequence of the rapid destruction of circulating B cells (7). This is why it is recommended to choose a low initial infusion rate. The incidence and the severity of infusion-related side effects consistently decrease in the successive administrations; indeed after the second rituximab infusion almost no B cells are left in the blood for at least 2 to 3 months. The reconstitution begins usually after 6 months and is completed after a median of 12 months (8, 9). We hypothesized that no infusion-related reaction should occur from the second infusion, and that a faster application of rituximab could be considered safe. Although the duration of the infusion is usually 4 to 5 hours for the first administration, the present study was undertaken to evaluate i...

Most patients with acute myeloid leukemia are older than 60 years, and their outcome is still disappointing. For younger patients, the prognosis is better if they receive high-dose cytarabine as post-remission therapy and if they are treated in the setting of a clinical trial.