Adjunctive use of azacitidine in patients with acute myeloid leukaemia (AML) or myelodysplasia (MDS) undergoing a reduced intensity conditioned allogeneic transplant
| ISRCTN | ISRCTN36825171 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36825171 |
| Secondary identifying numbers | RG 07-187 |
- Submission date
- 13/02/2008
- Registration date
- 20/03/2008
- Last edited
- 04/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Prof Charles Craddock
Scientific
Scientific
Centre for Clinical Haematology
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
| Phone | +44 (0)121 627 5824 |
|---|---|
| charles.craddock@uhb.nhs.uk |
Study information
| Study design | Phase II, multicentre, single arm, open-label, non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Phase ll study of the adjunctive use of azacitidine in patients undergoing reduced intensity allogeneic transplantation in acute myeloid leukaemia and myelodysplasia |
| Study acronym | RICAZA |
| 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. |
| Ethics approval(s) | West Midlands Research Ethics Committee on 24/04/2008 (ref: 08/H1208/4) |
| Condition | Acute myeloid leukaemia (AML) or myelodysplasia (MDS) |
| Intervention | 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. Total duration of trial treatment: 11 months; follow up period: 24 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Azacitidine |
| Primary outcome measure | 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 measures | 1. Relapse rate, assessed at 12 months post-transplant 2. Survival, assessed annually until 3 years post-transplant |
| Overall study start date | 01/06/2008 |
| Overall study end date | 31/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 patients |
| Total final enrolment | 37 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/06/2008 |
| Recruitment end date | 31/05/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Clinical Haematology
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Research and Commercial Services
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.rcs.bham.ac.uk |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Industry
Pharmion (UK)
No information available
University of Birmingham (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/04/2012 | Yes | No | |
| Plain English results | 04/04/2022 | No | Yes |
Editorial Notes
04/04/2022: Plain English results and total final enrolment added.
