Condition category
Cancer
Date applied
11/10/2013
Date assigned
11/10/2013
Last edited
24/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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).

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14772

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 below 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 measures

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

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, HIVpositive 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

School of Cancer Sciences
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

http://www.birmingham.ac.uk/

Funders

Funder type

Charity

Funder name

Leukaemia & Lymphoma Research (UK); Grant Codes: 12071

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes