title: 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).
abstract: The efficacy of a fixed-dose rituximab schedule was prospectively explored in primary/acute refractory, relapsed or chronic (platelet count >10 × 10(9) /l and ≤50 × 10(9) /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 >150 × 10(9) /l) or partial response (PR; platelet count >50 × 10(9) /l) was 44%. Therapeutic response, defined as achieving a response at week 8, with at least a minor response (MR; platelet count >30 × 10(9) /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/m(2) four-dose schedule in relapsed/chronic ITP.
authors.affiliation: Monash Medical Centre, Clayton, Vic., Australia; Australian Centre for Bloods Diseases, Monash University, Melbourne, Vic., Australia.
authors.forename: Huyen
authors.initials: H
authors.lastname: Tran
authors.forename: Tim
authors.initials: T
authors.lastname: Brighton
authors.forename: Andrew
authors.initials: A
authors.lastname: Grigg
authors.forename: Simon
authors.initials: S
authors.lastname: McRae
authors.forename: Joanna
authors.initials: J
authors.lastname: Dixon
authors.forename: Daniel
authors.initials: D
authors.lastname: Thurley
authors.forename: Maher K
authors.initials: MK
authors.lastname: Gandhi
authors.forename: Matt
authors.initials: M
authors.lastname: Truman
authors.forename: Paula
authors.initials: P
authors.lastname: Marlton
authors.forename: John
authors.initials: J
authors.lastname: Catalano
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D011446:Prospective Studies; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000097:blood / Q000188:drug therapy*; D012008:Recurrence; D000069283:Rituximab; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D007155:Immunologic Factors; D000069283:Rituximab
keywords: idiopathic thrombocytopenic purpura; platelet count; rituximab