| Source of record | UK Trials |
| ISRCTN | ISRCTN36825171 |
| Date ISRCTN assigned | 20/03/2008 |
| Local reference number(s) | RG 07-187 |
| Public title | Adjunctive use of azacitidine in patients with acute myeloid leukaemia (AML) or myelodysplasia (MDS) undergoing a reduced intensity conditioned allogeneic transplant |
| Scientific title | Phase ll study of the adjunctive use of azacitidine in patients undergoing reduced intensity allogeneic transplantation in acute myeloid leukaemia and myelodysplasia |
| Acronym | RICAZA |
| Disease/condition/study domain | Acute myeloid leukaemia (AML) or myelodysplasia (MDS) |
| Study hypothesis | Disease relapse is the major cause of treatment failure after allogeneic transplantation using reduced intensity conditioning (RIC) regimens in patients with acute myeloid leukaemia (AML) or myelodysplasia (MDS) and therefore strategies which reduce the risk of disease relapse are required. Although there has been interest in the use of prophylactic donor lymphocyte infusions (DLI) to reduce the risk of relapse, their use is associated with a significant risk of severe graft-versus-host disease (GVHD) when administered early post-transplant. Azacitidine has potent activity against malignant myeloid progenitors and this study aims to examine whether its administration post-transplant can modify the kinetics of disease relapse after a RIC allograft for AML or MDS thereby postponing or eliminating the requirement for DLI. |
| Design/methodology | Phase II, multicentre, single arm, open-label, non-randomised study |
| Research ethics review | Ethics approval pending from West Midlands Research Ethics Committee as of 20/03/2008 (submitted 1st February 2008). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients (male and female) between the age of 18 - 65 years in whom allogeneic transplantation using a myeloablative conditioning regimen is contra-indicated
2. Patients who fulfill the World Health Organization (WHO) criteria for AML or MDS
3. Patients with a human leukocyte antigen (HLA) identical sibling or suitable matched unrelated donor
4. Must give written informed consent and be able to comply with the protocol for the duration of the study |
| Participants - exclusion criteria | 1. Patients with contra-indications to receiving fludarabine or azacitidine
2. Pregnant or lactating women or adults of reproductive potential not willing to use appropriate medically approved contraception during the trial and for 12 months post-azacitidine
3. Any co-morbidity that in the investigators opinion will affect the patients participation in this study |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/06/2008 |
| Anticipated end date | 31/05/2011 |
| Status of trial | Ongoing |
| Target number of participants | 40 patients |
| Interventions | All participants will receive azacitidine administered six weeks after undergoing reduced intensity conditioned allogeneic transplantation. Azacitidine will be administered subcutaneously for 5 days for 10 cycles (each cycle being 28 days) at a dose of 36 mg/m^2. |
| Primary outcome measure(s) | Safety of azacitidine treatment. Adverse events and therapy-related side effects will be monitored continuously during azacitidine treatment and until 28 days after the last dose. |
| Secondary outcome measure(s) | 1. Relapse rate, assessed at 12 months post-transplant
2. Survival, assessed annually until 3 years post-transplant |
| Sources of funding | 1. Pharmion (UK)
2. University of Birmingham (UK) |
| Sponsor name | University of Birmingham (UK) |
| Sponsor details | Research and Commercial Services
Edgbaston
Birmingham
United Kingdom
B15 2TT |
| Sponsor website | http://www.rcs.bham.ac.uk |
| Contact name | Prof Charles Craddock |
| Contact details | Centre for Clinical Haematology
Queen Elizabeth Hospital
Edgbaston
Birmingham
United Kingdom
B15 2TH |
| Contact telephone | +44 (0)121 627 5824 |
| Contact fax | +44 (0)121 627 2226 |
| Contact email | charles.craddock@uhb.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN36825171 |
| Date last extracted from ISRCTN register | 17/04/2008 |
