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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:
1. AML
  1. Patients in 1st complete remission (CR1) with adverse risk cytogenetics (see Appendix 3)
  2. Patients in 2nd complete remission (CR2)
  3. Patients with primary refractory AML defined as the failure to achieve a morphological remission after 2 courses of induction chemotherapy
  4. Patients with Flt-3 ITD positive AML
  5. Patients with persistent or rising MRD levels (by immunophenotypic or molecular monitoring) who have a morphological CR
  6. Patients who have been defined as high risk according to the UK NCRI AML17 (or the subsequent AML19) clinical trial
  7. Patients who have been defined as high risk by MRD criteria according to the UK NCRI AML17, AML18 (or the subsequent AML19) clinical trials
2. MDS
  1. 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
  2. Patients aged equal to or greater than 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 DRβ1)
  4. 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
  5. Resolution of any toxic effects of prior therapy (including radiotherapy, chemotherapy or surgical procedures)
  6. Performance of cardiac or pulmonary function tests (where there is a previous history of cardiac or pulmonary impairment)
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

Research Nurse

Stewart McConnell

Tel: 01132068577

E-mail: stewart.mcconnell@nhs.net

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