Contact information
Type
Scientific
Primary contact
Dr Sarah Essex
ORCID ID
Contact details
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
figaro@trials.bham.ac.uk
Additional identifiers
EudraCT number
2012-005538-12
ClinicalTrials.gov number
Protocol/serial number
14772
Study information
Scientific title
A randomised trial of the FLAMSA-BU conditioning regimen in patients with acute myeloid leukaemia and myelodysplasia undergoing allogeneic stem cell transplantation
Acronym
FIGARO
Study hypothesis
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
NRES Committee Yorkshire & The Humber Sheffield, 03/06/2013, ref: 13/YH/0152
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Phase II
Drug names
Fludarabine, cytarabine, amsacrine, busulphan
Primary outcome measure
Overall survivial, 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 trial start date
10/10/2013
Overall trial end date
31/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 170
Participant 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
Recruitment start date
10/10/2013
Recruitment end date
31/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
Figaro@trials.bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Leukaemia and Lymphoma Research; Grant Codes: 12071
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list