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)

Tran, Huyen, Brighton, Tim, Grigg, Andrew, McRae, Simon, Dixon, Joanna, Thurley, Daniel, Gandhi, Maher K., Truman, Matt, Marlton, Paula and Catalano, John (2014) 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). British Journal of Haematology, 167 2: 243-251. doi:10.1111/bjh.13029


Author Tran, Huyen
Brighton, Tim
Grigg, Andrew
McRae, Simon
Dixon, Joanna
Thurley, Daniel
Gandhi, Maher K.
Truman, Matt
Marlton, Paula
Catalano, John
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)
Journal name British Journal of Haematology   Check publisher's open access policy
ISSN 0007-1048
1365-2141
Publication date 2014-10
Year available 2014
Sub-type Article (original research)
DOI 10.1111/bjh.13029
Volume 167
Issue 2
Start page 243
End page 251
Total pages 9
Place of publication Chichester, West Sussex, United Kingdom
Publisher Wiley-Blackwell Publishing
Collection year 2015
Language eng
Abstract The efficacy of a fixed-dose rituximab schedule was prospectively explored in primary/acute refractory, relapsed or chronic (platelet count >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 >150 × 109/l) or partial response (PR; platelet count >50 × 109/l) was 44%. Therapeutic response, defined as achieving a response at week 8, with at least a minor response (MR; platelet count >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.
Keyword Idiopathic thrombocytopenic purpura
Rituximab
Platelet count
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Medicine Publications
 
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