Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Contact information



Primary contact

Dr Sarah Essex


Contact details

School of Cancer Sciences
University of Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

2012-005538-12 number

Protocol/serial number


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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (acute myeloid)


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



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


Overall trial end date


Reason abandoned (if study stopped)


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:
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
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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
B15 2TT
United Kingdom

Sponsor information


University of Birmingham (UK)

Sponsor details

B15 2TT
United Kingdom

Sponsor type




Funder type


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


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

Publication citations

Additional files

Editorial Notes

09/11/2017: No publications found, verifying study status with principal investigator.