Clinical effectiveness and cost-effectiveness results from the randomised, Phase IIB trial in previously untreated patients with chronic lymphocytic leukaemia to compare fludarabine, cyclophosphamide and rituximab with fludarabine, cyclophosphamide, mitoxantrone and low-dose rituximab: the Attenuated dose Rituximab with ChemoTherapy In Chronic lymphocytic leukaemia (ARCTIC) trial

Howard D R, Munir T, McParland L, Rawstron A C, Chalmers A, Gregory W M, O'Dwyer J L, Smith A, Longo R, Varghese A, Smith A & Hillmen P
Record ID 32010000356
English
Authors' objectives: To assess whether fludarabine, cyclophosphamide, mitoxantrone and low-dose rituximab (FCM-miniR) (100 mg of rituximab per cycle) was non-inferior to FCR in frontline CLL. Complete response (CR) rate was the primary end point, with the secondary end points being progression-free survival (PFS), overall survival (OS), overall response rate, eradication of minimal residual disease (MRD), safety and cost-effectiveness.
Authors' recommendations: FCM-miniR is less well tolerated, with poorer response rates, than FCR, partly owing to the additional toxicity associated with mitoxantrone. In view of this, FCM-miniR will not be taken forward into a larger definitive Phase III trial. The trial demonstrated that oral FCR yields extremely high response rates compared with historical series with intravenous chemotherapy.
Details
Project Status: Completed
URL for project: http://www.nets.nihr.ac.uk/projects/hta/070138
Year Published: 2017
URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/hta21280/#/abstract
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Antibodies, Monoclonal
  • Antineoplastic Combined Chemotherapy Protocols
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Vidarabine
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: <p>2010 Queen's Printer and Controller of HMSO</p>
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