FLAMSA-BU conditioning regimen in patients with acute myeloid leukaemia and myelodysplasia undergoing allogeneic stem cell transplantation
ISRCTN | ISRCTN50855000 |
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DOI | https://doi.org/10.1186/ISRCTN50855000 |
EudraCT/CTIS number | 2012-005538-12 |
Secondary identifying numbers | 14772 |
- Submission date
- 11/10/2013
- Registration date
- 11/10/2013
- Last edited
- 12/05/2022
- 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 of protocol
Contact information
Dr Sarah Essex
Scientific
Scientific
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
figaro@trials.bham.ac.uk |
Study information
Study design | Randomised interventional treatment trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | A randomised trial of the FLAMSA-BU conditioning regimen in patients with acute myeloid leukaemia and myelodysplasia undergoing allogeneic stem cell transplantation |
Study acronym | FIGARO |
Study objectives | This is a prospective, phase II, multicentre, randomised clinical trial in patients with acute myeloid leukaemia (AML) or myelodysplasia (MDS) undergoing reduced intensity conditioning (RIC) allogeneic stem cell transplantation (SCT) comparing the novel conditioning regimen (fludarabine/cytarabine/amsacrine/busulphan/ATG) (FLAMSA-BU) with standard conditioning regimens fludarabine/melphalan/alemtuzumab (FMA), fludarabine/busulphan/alemtuzumab (FBA) or fludarabine/busulphan/ATG (FB-ATG). |
Ethics approval(s) | NRES Committee Yorkshire & The Humber Sheffield, 03/06/2013, ref: 13/YH/0152 |
Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (acute myeloid) |
Intervention | Patients will be stratified at randomisation by their underlying disease (AML; MDS), cytogenetic risk group (adverse risk; intermediate or good risk), disease status at transplant [1st complete remission (CR1) or 2nd complete remission (CR2)]; primary refractory disease, intended control arm regimen (FMA; FBA; FB-ATG), age (above; below 60 years of age) and by donor type (sibling; unrelated). Patients eligible for entry into the trial will be randomised on a 1:1 basis Standard conditioning regimens fludarabine/melphalan/alemtuzumab (FMA), fludarabine/busulphan/alemtuzumab (FBA) or fludarabine/busulphan/ATG (FB-ATG). Novel conditioning regimen, Using fludarabine, cytarabine, amsacrine, busulphan and ATG combined to condition the patients for a reduced intensity stem cell transplant. The interventions are from 7 to 12 days depending in which treatment arm is selected. The follow-up is 24 months for both arms. Study Entry : Single Randomisation only |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Fludarabine, cytarabine, amsacrine, busulphan |
Primary outcome measure | Overall survival, measured using date of death from any cause; Timepoints: 24 months post transplant |
Secondary outcome measures | 1. Disease relapse, measured using date of relapse; Timepoint(s): Disease relapse within the 24 month follow up 2. Event free survival, measured using date of relapse or date of death; Timepoint(s): 24 months post transplant 3. Incidence of graft versus host disease (GvHD), measured counting episodes of GvHD; Timepoint(s): Throughout the 24 month follow up 4. Quality of Life; Timepoint(s): FACT-BMT questionnaire, completed pre-tranplant, at day 42 and month 3, 6, 9, 12, 18 and 24. 5. Transplant related mortality measured by any death related to transplant procedure, not underlying, disease at day 100 and 12 months post-transplant |
Overall study start date | 10/10/2013 |
Completion date | 31/10/2015 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | UK Sample Size: 170 |
Total final enrolment | 244 |
Key inclusion criteria | 1. Patients with a morphologically documented diagnosis of AML or MDS clinically indicated to receive a RIC allograft with one the following disease characteristics: AML 1.1. Patients in 1st complete remission (CR1) with adverse risk cytogenetics 1.2. Patients in 2nd complete remission (CR2) 1.3. Patients with primary refractory AML defined as the failure to achieve a morphological remission after 2 courses of induction chemotherapy 1.4. Patients participating in the UK NCRN AML17 (or the subsequent AML19) clinical trial who have been defined as high risk (based upon age, de novo or secondary disease, cytogenetics, white blood count, sex and response to course 1) 1.5. Patients participating in the UK NCRN AML17, AML18 (or the subsequent AML19) clinical trials who have been defined as high risk by Minimal Residual Disease (MRD) criteria MDS 1.6. Patients with advanced MDS (defined by an IPSS score of INT1 with >5% blasts or INT2 or high risk ) who have < 5% blasts at the time of randomisation following chemotherapy or hypomethylating agents if necessary 2. Patients aged ≥ 16 years 3. Patients with an HLA identical sibling or suitable matched unrelated donor (suitable match defined as no greater than a single allele mismatch at HLA A, B, C or DRB1) 4. Patients considered suitable to undergo a reduced intensity conditioned allogeneic stem cell transplant as clinically judged by the Local Investigator including: 4.1. Adequate cardiac, pulmonary, hepatic and renal function as determined by pre-transplant assessments 4.2. Resolution of any toxic effects of prior therapy (including radiotherapy, chemotherapy or surgical procedures) 5. Patients with an ECOG performance status of 0, 1 or 2 6. Patients have given written informed consent 7. Patients willing and able to comply with scheduled study visits and laboratory tests |
Key exclusion criteria | 1. Patients with chemorefractory relapse of AML or MDS 2. Patients with contraindications to receiving RIC allogeneic SCT 3. Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment 4. Adults of reproductive potential not willing to use appropriate, effective, contraception during the specified period 5. Patients with clinically significant cardiac disease (New York Heart Association, Class III or IV) 6. Patients with renal or hepatic impairment as clinically judged by Local Investigator 7. Patients with active infection, HIV positive or chronic active Hep A, B, C 8. Patients with concurrent active malignancy |
Date of first enrolment | 10/10/2013 |
Date of final enrolment | 31/10/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
Figaro@trials.bham.ac.uk | |
Website | http://www.birmingham.ac.uk/ |
https://ror.org/03angcq70 |
Funders
Funder type
Charity
Leukaemia and Lymphoma Research; Grant Codes: 12071
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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? |
---|---|---|---|---|---|
Abstract results | Presented at ASH | 13/11/2019 | 12/05/2022 | No | No |
Basic results | 23/01/2022 | 12/05/2022 | No | No | |
Plain English results | 10/05/2022 | 12/05/2022 | No | Yes | |
Results article | 01/03/2021 | 12/05/2022 | Yes | No | |
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
12/05/2022: The following changes have been made:
1. A plain English results link has been added.
2. Publication references added.
3. The final enrolment number has been added from the reference.
4. A basic results link has been added.
09/11/2017: No publications found, verifying study status with principal investigator.