RICMAC version 5

• Research type

  Research Study

• Full title

  Dose-reduced versus standard conditioning followed by allogeneic stem cell transplantation in patients with MDS or sAML: A randomised phase III study by the European Group for Blood and Marrow Transplantation (RICMAC)

• Sponsor organisation

  European Group for Blood and Marrow Transplantation

• Eudract number

  2005-002011-24

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  The aim of this study is to show that dose-reduced pre transplant chemotherapy will result in less lethal therapy-related complications but with the same chance of cure. A malignant disease like myelodysplastic syndrome or secondary acute myeloid leukaemia can be treated with stem cell transplantation. This means that the patients’ blood and/or bone marrow cells will be replaced with new blood and/or bone marrow cells. Allogenieic stem cell (stem cells derived from a donor such as a family donor or voluntary unrelated donor) transplantation is the only therapy with realistic curative prospects. The patient will be treated either with dose-reduced or with standard conditioning prior to allogeneic stem cell transplantation. However, to have well-balanced groups of patients in both arms, the patient will be "randomised". After the collection of the peripheral blood stem cells / bone marrow from a donor and prior to the actual transplantation process participants will receive standard conditioning chemotherapy with either busulfan plus cyclophosphamide (Arm A) or reduced-intensity conditioning with busulfan plufluarabine (Arm B). After the pre-treatment participants will have the stem cells from their donor injected (= transplanted). After the bone marrow / blood stem cell transplantation, participants will receive two drugs (cyclosporine A andmethotrexate) to prevent an immune reaction of the donor lymphocytes, the so-called graft-versus-host-reaction. The primary objective of the study is to compare overall survival and incidence of transplant-related mortality between study arms.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  08/H0808/180

• Date of REC Opinion

  29 Oct 2008

• REC opinion

  Further Information Favourable Opinion