REACH 3

• 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 chronic graft vs host disease after allogenic stem cell transplantation (REACH 3)

• IRAS ID

  228268

• Contact name

  Ronjon Chakraverty

• Contact email

  r.chakraverty@ucl.ac.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2016-004432-38

• Clinicaltrials.gov Identifier

  NCT03112603

• Duration of Study in the UK

  4 years, 6 months, 4 days

• Research summary

  Graft vs Host Disease (GvHD) can occur in patients who have had a stem cell transplant. GvHD occurs when cells from the donor transplant see the transplant recipient (the patient who is receiving the transplant) as ‘foreign’ and ‘attack’ it. This is an unwanted side-effect of the transplant. The side-effects vary quite a lot between patients. Usually chronic GvHD is treated with steroids but for over half of patients these stop working properly. This is referred to as being steroid refractory. There is currently no widely approved treatment for these patients. The purpose of the study is to compare Ruxolitinib with the best available therapy (BAT) and its effect on disease response
  Patients will be randomly assigned to one of two treatment groups either.
  Group 1: Treatment with BAT
  Group 2: Treatment with Ruxolitinib

  For Group 1 the best available therapy will be selected by the study doctor.
  Group 2 patient will receive Ruxolitinib as tablets orally
  If a patient is randomised to group 1 and are not responding at any time after cycle 7(1 cycle=28 days) they can cross over to group 2
  The study will enroll 324 patients globally. The study will include patients age 12 or older, who have:
  • undergone Allogeneic Stem Cell Transplantation (alloHSCT),
  • evidence of engraftment
  • been diagnosed with moderate to severe cGvHD
  • had a lack of response or progression while on steroids.
  All patients will be treated and/or followed on study for a total of 3 years. Treatment can continue until GVHD progression or withdrawal from the study for other reasons.
  The following tests will be required as part of the study:
  • Physical exam
  • Blood samples
  • Urine samples
  • Cheek swabs
  • Lung function tests
  • Pregnancy tests, if applicable
  • Children(< 18) will receive a bone density ( DEXA scans)

  Research summary:
  The English lay summary will be posted publicly on Novartis public website https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.novctrd.com%2F&data=05%7C01%7Criverside.rec%40hra.nhs.uk%7Ce47ac3d3134641af057508db9e77ba48%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638278009301860967%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=XW96xIHWCuL7xHWZpFvjtlXthhJwPBuL%2BqlX3m3QI%2B0%3D&reserved=0 one year post global LPLV

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  17/LO/1306

• Date of REC Opinion

  5 Oct 2017

• REC opinion

  Further Information Favourable Opinion