REACH 2
Research type
Research Study
Full title
A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogenic stem cell transplantation
IRAS ID
220433
Contact name
Ronjon Chakraverty
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2016-002584-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
The study will enrol 308 patients globally that include male or female patients ages 12 or older, who have undergone Allogeneic Stem Cell Transplantation (alloHSCT), have evidence of myeloid engraftment (ANC >1,000/μl), and have been diagnosed with Acute Graft vs. Host Disease (aGVHD) requiring systemic treatment (NIH grade II-IV) which is determined to be steroid-resistant, per standard criteria.
Subjects will be randomized 1:1 to receive either ruxolitinib or BAT stratifying on GvHD grade (Grade II vs. III vs. IV), and receive treatment for minimum 6 months unless intolerable toxicity,GVHD progression, or withdrawal from the study for other reasons occurs.
Ruxolitinib at a starting dose of 10mg PO BID.Crossover from best available therapy(BAT) to Ruxolitinib is allowed after day 28 in patients who do not achieve a complete response (CR) or partial response(PR) at Day 28 after randomization or those who lose the response thereafter.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0372
Date of REC Opinion
14 Jun 2017
REC opinion
Further Information Favourable Opinion