RATinG: Risk Adapted Therapy in Acute GvHD

• Research type

  Research Study

• Full title

  RATinG (Risk Adapted Therapy in acute GvHD): Investigating the use of lenzilumab for treating high-risk acute graft versus host disease following allogeneic stem cell transplantation

• IRAS ID

  286785

• Contact name

  Adrian Bloor

• Contact email

  adrian.bloor@christie.nhs.uk

• Sponsor organisation

  University of Birmingham

• Eudract number

  2021-001193-29

• ISRCTN Number

  ISRCTN42585840

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  Donor stem cell transplantation is used for treating patients with blood cancers. This is also called allogeneic stem cell transplantation. It is a very intense form of treatment which can cause significant complications. Graft versus host disease (GvHD) is one of the most serious side effects and occurs when the donor immune system attacks the normal tissues in the transplant recipient. There are two types of GvHD. Acute GvHD normally happens within 100 days of the transplant and chronic GvHD happens later.
  Acute GvHD occurs in about half of stem cell transplants, and many patients don’t respond well to standard treatment. Blood tests have recently been developed which can identify patients with high risk acute GvHD. This is a randomised trial which means that half of the patients with high risk disease will be receive lenzilumab and the other half will receive a placebo.
  The key aims of this trial are as listed below:
  • To use blood tests (called biomarkers) to identify patients with high risk acute GvHD following donor stem cell transplant
  • To investigate a new drug called lenzilumab for treating patients with high risk acute GvHD

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  21/EM/0280

• Date of REC Opinion

  5 Jan 2022

• REC opinion

  Further Information Favourable Opinion