A multicenter, randomised, open-label, three-parallel groups, phase 2-3 study to evaluate the efficacy and safety of masitinib with dexamethasone, gemcitabine with dexamethasone and the combination of masitinib, gemcitabine and dexamethasone in patients with relapsed or refractory peripheral T-cell lymphoma.
Phase of Trial: Phase II/III
Latest Information Update: 16 Feb 2017
At a glance
- Drugs Masitinib (Primary) ; Dexamethasone; Gemcitabine
- Indications Peripheral T-cell lymphoma
- Focus Registrational; Therapeutic Use
- Sponsors AB Science
- 27 May 2015 According to an AB Science media release, Health authorities from 14 countries agreed to transform this phase II study directly into phase III, with prospective recruitment of 270 patients. The decision to accelerate the phase II into phase III was based on the observation of a survival benefit with masitinib as compared to control and acceptable safety with validation of the passage into phase 3 by the independent Data Monitoring Safety Board.
- 27 May 2015 Planned number of patients changed from 255 to 270 according to an AB Science media release.
- 07 Feb 2015 New source identified and integrated (European Clinical Trials Database record:EudraCT2010-021091-28)