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Trial Overview
A Randomised Trial of the FLAMSA-BU CondItioning ReGimen in Patients with Acute Myeloid Leukaemia and Myelodysplasia UndeRgoing AllOgeneic Stem Cell Transplantation
Inclusion criteria
- Patients with a morphologically documented diagnosis of AML (Appendix 1) or MDS (Appendix 2) who are clinically indicated to receive a RIC allograft with one the following disease characteristics:
- AML
- Patients in 1st complete remission (CR1) with adverse risk cytogenetics (see Appendix 3)
- Patients in 2nd complete remission (CR2)
- Patients with primary refractory AML defined as the failure to achieve a morphological remission after 2 courses of induction chemotherapy
- Patients with Flt-3 ITD positive AML
- Patients with persistent or rising MRD levels (by immunophenotypic or molecular monitoring) who have a morphological CR
- Patients who have been defined as high risk according to the UK NCRI AML17 (or the subsequent AML19) clinical trial
- Patients who have been defined as high risk by MRD criteria according to the UK NCRI AML17, AML18 (or the subsequent AML19) clinical trials
- MDS
- Patients with advanced MDS (defined by an IPSS score of INT-1 with >5% blasts or INT-2 or high risk) who have < 10% blasts at the time of randomisation following chemotherapy or hypomethylating agents if necessary
- Patients aged equal to or greater than 16 years
- 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 DRβ1)
- Patients considered suitable to undergo a reduced intensity conditioned allogeneic SCT as clinically judged by the Local Investigator including:- Adequate hepatic and renal function as determined by full blood count and biochemistry assessment
- Resolution of any toxic effects of prior therapy (including radiotherapy, chemotherapy or surgical procedures)
- Performance of cardiac or pulmonary function tests (where there is a previous history of cardiac or pulmonary impairment)
- AML
- Patients with an ECOG performance status 0,1 or 2
- Patients of reproductive potential must be willing to use appropriate, effective, contraception from the point of admission for transplant conditioning therapy until 6 months after the transplant
- Patients have given written informed consent
- Patients willing and able to comply with scheduled study visits and laboratory tests
Exclusion criteria
- Patients with chemo-refractory relapse of AML or MDS
- Patients with contraindications to receiving RIC allogeneic SCT
- Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment
- Adults of reproductive potential not willing to use appropriate, effective, contraception during the specified period
- Patients with renal or hepatic impairment as clinically judged by Local Investigator
- Patients with active infection, HIV-positive or chronic active Hep-A, -B, -C
- Patients with concurrent active malignancy

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