A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT

Inclusion Criteria

• •1. Patients (≥ 18 years old) with a morphological documented diagnosis of AML or MDS who are deemed fit for allo-SCT with one of the following disease characteristics:
• •AML
• •* Patients in 1st complete remission (CR1) defined as \< 5% blasts
• •* Patients in 2nd complete remission (CR2) defined as \< 5% blasts
• •* Secondary AML (defined as previous history of MDS, antecedent haematological disease or chemotherapy exposure) in CR1 or 2 defined as \< 5% blasts MDS
• •* Patients with advanced or high risk MDS with an IPSS-R of ≥3.5 (intermediate 3.5 or higher) including intermediate or high risk CMML (e.g. CPSS int-2 or high risk)
• •2. Patients with an identified HLA identical sibling or suitable matched unrelated donor (suitable match defined as no greater than a single allele mismatch at HLA-A, -B, -C, DQB1 or DRβ1)
• •3. Patients must be considered suitable/fit to undergo allo-SCT as clinically judged by the Local Investigator
• •4. Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must use appropriate, highly effective, contraception from the point of commencing therapy until 6 months after treatment
• •5. Patients have given written informed consent
• •1. Patients aged between 18 - 54 years with a morphological documented diagnosis of AML or MDS who are deemed fit for a MAC allo-SCT with one of the following disease characteristics: AML o Patients in 1st complete remission (CR1) defined as \< 5% blasts
• •* Patients in 2nd complete remission (CR2) defined as \< 5% blasts
• •* Secondary AML (defined as previous history of MDS, antecedent haematological disease or chemotherapy exposure) in CR1 or 2 defined as \< 5% blasts
• •* Must have received at least two courses of prior intensive chemotherapy prior to transplant unless there are exceptional circumstances. Patients with AML who have achieved CR with Venetoclax based induction regimen treatment as only prior treatment, will also be eligible.
• •MDS
• •o Patients with advanced or high risk MDS (with an IPSS-R of ≥3.5 (intermediate 3.5 or higher) including intermediate or high risk CMML (e.g. CPSS int-2 or high risk), who have \< 10% blasts at the time of randomisation following intensive chemotherapy (including R1 randomisation) or hypomethylating agents if necessary
• •2. Patients with an identified HLA identical sibling or suitable matched unrelated donor (suitable match defined as no greater than a single allele mismatch at HLA-A, -B, -C, DQB1 or DRβ1)
• •3. Patients with an ECOG performance status of 0, 1 or 2
• •4. Patients considered suitable/fit to undergo a MAC allo-SCT as clinically judged by the Local Investigator including:
• •1. Adequate hepatic and renal function as determined by full blood count and biochemistry assessment
• •2. Resolution of any toxic effects of prior therapy (including radiotherapy, chemotherapy or surgical procedures)
• •3. Performance of cardiac or pulmonary function tests (where there is a previous history of cardiac or pulmonary impairment)
• •5. Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must use appropriate, highly effective, contraception from the point of commencing therapy until 12 months after treatment
• •6. Patients have given written informed consent
• •Patients in 1st complete remission (CR1) defined as \< 5% blasts
• •Patients in 2nd complete remission (CR2) defined as \< 5% blasts
• •Secondary AML (defined as previous history of MDS, antecedent haematological disease or chemotherapy exposure) in CR1 or 2 defined as \< 5% blasts
• •Must have received at least two courses of prior intensive chemotherapy prior to transplant unless there are exceptional circumstances. Patients with AML who have achieved CR with Venetoclax based induction regimen treatment, as only prior treatment, will also be eligible.
• •MDS