COSI

COSI: A Randomised Trial of Therapeutic Interventions with the Potential to Improve Outcome in Older Patients with High Risk Acute Myeloid Leukaemia and Myelodysplasia Undergoing Allogeneic Stem Cell Transplantation

Study design/summary: This is a randomised phase II/III, multicentre, clinical trial incorporating a multi-arm-multi-stage (MAMS) design in patients with acute myeloid leukaemia (AML) and myelodysplasia syndrome (MDS) undergoing stem cell transplantation (SCT)

Objectives:

  1. To compare the novel pre-transplant consolidation therapy CPX351 with the standard consolidation therapy (intermediate dose of cytosine arabinoside)
  2. To compare novel conditioning therapies in patients under the age of 60 years
  3. To compare novel conditioning therapies in patients aged 60 and over

Centres: 22 IMPACT centres

Target Number of patients: Up to 860 patients

Patient population: Patients with AML and MDS who are suitable to undergo a reduced intensity conditioned allogeneic stem cell transplant

Sponsorship/Funding: University of Birmingham, funded by the IMPACT network

Useful links: COSI trial webpage CRCTU (Not yet active)

Trial Status: In set-up

Trial Contacts: Andrea Hodgkinson (Trial Coordinator) COSI@trials.bham.ac.uk

Start Date: Planned Q3 of 2018

Duration: 6-7 years

If you are a patient and interested in taking part in a clinical trial, please speak with your consultant who will be able to offer you further information and discuss whether it is suitable for you. A referral from your medical team would be required in order to consider you for treatment on a clinical trial.