A multi‐centre, single‐arm, open‐label study evaluating the safety and efficacy of fixed dose rituximab in patients with refractory, relapsed or chronic idiopathic thrombocytopenic purpura (R‐ITP1000 study). (11th July 2014)

• Record Type: Journal Article
• Authors: Tran, Huyen; Brighton, Tim; Grigg, Andrew; McRae, Simon; Dixon, Joanna; Thurley, Daniel; Gandhi, Maher K.; Truman, Matt; Marlton, Paula; Catalano, John
• Is Part Of: British journal of haematology. Volume 167:Number 2(2014:Oct.)
• Page Start: 243
• Page End: 251
• Publication Date: 2014-07-11
• Subjects: Hematology -- Periodicals; Blood -- Diseases -- Periodicals; 616.15
• DOI: 10.1111/bjh.13029
• Languages: English
• ISSNs: 0007-1048

Abstract

<abstract abstract-type="main" id="bjh13029-abs-0001"> <title>Summary</title> <p>The efficacy of a fixed‐dose rituximab schedule was prospectively explored in primary/acute refractory, relapsed or chronic (platelet count &gt;10 × 10⁹/l and ≤50 × 10⁹/l) idiopathic thrombocytopenic purpura (ITP). Patients received two doses of rituximab (1000 mg) on days 1 and 15 and were followed‐up on weeks 1–8, 12, 26, 39 and 52. A total of 122 patients were included in the safety population; efficacy was analysed in 108 patients. Overall response rate (ORR) at week 8, defined as the proportion of patients achieving complete response (CR; platelet count &gt;150 × 10⁹/l) or partial response (PR; platelet count &gt;50 × 10⁹/l) was 44%. Therapeutic response, defined as achieving a response at week 8, with at least a minor response (MR; platelet count &gt;30 × 10⁹/l), sustained up to weeks 26 and 52 and accompanied by a reduction in ITP medications, was achieved in 44% (week 26) and 35% (week 52) of patients, respectively. Treatment was well tolerated with no safety concerns. While this study failed to meet its primary endpoint of an ORR of 50%, the efficacy of two fixed doses of rituximab appear to provide similar efficacy to the standard 375 mg/m² four‐dose schedule in relapsed/chronic ITP.</p> </abstract>