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b'Patients with contraindications to receiving allo-SCT'
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b'Patients who have already received Vyxeos in their most recent treatment schedule'
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b'Female patients who are pregnant or breastfeeding. All women of childbearing potential'
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b'must have a negative pregnancy test before commencing treatment'
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b'Adults of reproductive potential not willing to use appropriate, highly effective,'
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b'contraception during the specified period'
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b'Patients with renal or hepatic impairment as clinically judged by the Local'
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b'Investigator'
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b'Patients with active infection, HIV-positive or chronic active HBV or HCV.'
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b'Patients with a prior malignancy, except lobular breast carcinoma in situ, fully'
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b'resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma'
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b'in situ. Cancer treated with curative intent \\u2265 5 years previously will be allowed.'
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b'Cancer treated with curative intent < 5 years previously will not be allowed'
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b'History of serious hypersensitivity reaction to cytarabine, daunorubicin, or any'
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b'component of the Vyxeos formulation.'
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b"Known history of Wilson's disease or other copper-related metabolic disorder since"
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b'copper gluconate is a component of the Vyxeos formulation'
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b'Eligibility Criteria for Randomisation 2 Inclusion Criteria for Randomisation 2'
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b'Patients aged between 18 - 54 years with a morphological documented diagnosis of AML'
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b'or MDS who are deemed fit for a MAC allo-SCT with one of the following disease'
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b'characteristics: AML'
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b'Patients in 1st complete remission (CR1) defined as < 5% blasts'
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b'Patients in 2nd complete remission (CR2) defined as < 5% blasts'
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b'Secondary AML (defined as previous history of MDS, antecedent haematological'
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b'disease or chemotherapy exposure) in CR1 or 2 defined as < 5% blasts'
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b'Must have received at least two courses of prior intensive chemotherapy prior to'
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b'transplant unless there are exceptional circumstances MDS'
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b'Patients with advanced or high risk MDS (with an IPSS-R of \\u22653.5 (intermediate 3.5'
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b'or higher) who have < 10% blasts at the time of randomisation following intensive'
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b'chemotherapy (including R1 randomisation) or hypomethylating agents if necessary'
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b'Patients with an identified HLA identical sibling or suitable matched unrelated donor'
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b'(suitable match defined as no greater than a single allele mismatch at HLA-A, -B, -C'
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b'or DR\\u03b21)'
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b'Patients with an ECOG performance status of 0, 1 or 2'
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b'Patients considered suitable/fit to undergo a MAC allo-SCT as clinically judged by the'
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b'Local Investigator including:'
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b'Adequate hepatic and renal function as determined by full blood count and'
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b'biochemistry assessment'
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b'Resolution of any toxic effects of prior therapy (including radiotherapy,'
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b'chemotherapy or surgical procedures)'
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b'Performance of cardiac or pulmonary function tests (where there is a previous'
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b'history of cardiac or pulmonary impairment)'
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b'Females of and male patients of reproductive potential (i.e., not post-menopausal or'
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b'urgically sterilised) must use appropriate, highly effective, contraception from the'
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b'point of commencing therapy until 12 months after treatment'
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b'Patients have given written informed consent'
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b'Patients willing and able to comply with scheduled study visits and laboratory tests'
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b'Patients with contraindications to receiving a MAC allo-SCT 2. Female patients who are'
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b'pregnant or breastfeeding. All women of childbearing potential must have a negative'
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b'pregnancy test before commencing treatment 3. Adults of reproductive potential not willing'
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b'to use appropriate, effective, contraception during the specified period 4. Patients with'
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b'renal or hepatic impairment as clinically judged by the Local Investigator 5. Patients with'
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b'active infection, HIV-positive or chronic active HBV or HCV 6. Patients with a prior'
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b'malignancy, except lobular breast carcinoma in situ, fully resected basal cell or squamous'
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|
|
|
b'cell carcinoma of skin or treated cervical carcinoma in situ. Cancer treated with curative'
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|
|
|
b'intent \\u2265 5 years previously will be allowed. Cancer treated with curative intent < 5 years'
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b'previously will not be allowed.'
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b'Eligibility Criteria for Randomisation 3 Inclusion Criteria for Randomisation 3'
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b'Patients aged between 55 years or older with a morphological documented diagnosis of'
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b'AML or MDS who are deemed fit for a RIC allo-SCT with one of the following disease'
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b'characteristics:'
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b'AML o Patients in 1st complete remission (CR1) defined as < 5% blasts'
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|
b'o Patients in 2nd complete remission (CR2) defined as < 5% blasts'
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|
|
|
|
b'o Secondary AML (defined as previous history of MDS, antecedent haematological disease'
|
|
|
|
|
b'or chemotherapy exposure) in CR1 or 2 defined as < 5% blasts'
|
|
|
|
|
b'o Must have received at least two courses of prior intensive chemotherapy prior to'
|
|
|
|
|
b'transplant unless there are exceptional circumstances MDS'
|
|
|
|
|
b'Patients with advanced or high risk MDS (with an IPSS-R of \\u22653.5 (intermediate 3.5'
|
|
|
|
|
b'or higher) who have < 10% blasts at the time of randomisation following intensive'
|
|
|
|
|
b'chemotherapy (including R1 randomisation) or hypomethylating agents if necessary'
|
|
|
|
|
b'Patients with an identified HLA identical sibling or suitable matched unrelated donor'
|
|
|
|
|
b'(suitable match defined as no greater than a single allele mismatch at HLA-A, -B, -C'
|
|
|
|
|
b'or DR\\u03b21)'
|
|
|
|
|
b'Patients with an ECOG performance status of 0, 1 or 2'
|
|
|
|
|
b'Patients considered suitable/fit to undergo a RIC allo-SCT as clinically judged by the'
|
|
|
|
|
b'Local Investigator including:'
|
|
|
|
|
b'Adequate hepatic and renal function as determined by full blood count and'
|
|
|
|
|
b'biochemistry assessment'
|
|
|
|
|
b'Resolution of any toxic effects of prior therapy (including radiotherapy,'
|
|
|
|
|
b'chemotherapy or surgical procedures)'
|
|
|
|
|
b'Performance of cardiac or pulmonary function tests (where there is a previous'
|
|
|
|
|
b'history of cardiac or pulmonary impairment'
|
|
|
|
|
b'Females of and male patients of reproductive potential (i.e., not post-menopausal or'
|
|
|
|
|
b'urgically sterilised) must use appropriate, highly effective, contraception from the'
|
|
|
|
|
b'point of commencing therapy until 12 months after treatment'
|
|
|
|
|
b'Patients have given written informed consent'
|
|
|
|
|
b'Patients willing and able to comply with scheduled study visits and laboratory tests'
|
|
|
|
|
b'Patients with contraindications to receiving a RIC allo-SCT 2. Female patients who are'
|
|
|
|
|
b'pregnant or breastfeeding. All women of childbearing potential must have a negative'
|
|
|
|
|
b'pregnancy test before commencing treatment 3. Adults of reproductive potential not willing'
|
|
|
|
|
b'to use appropriate, effective, contraception during the specified period 4. Patients with'
|
|
|
|
|
b'renal or hepatic impairment as clinically judged by the Local Investigator 5. Patients with'
|
|
|
|
|
b'active infection, HIV-positive or chronic active HBV or HCV 6. Patients with a prior'
|
|
|
|
|
b'malignancies, except lobular breast carcinoma in situ, fully resected basal cell or'
|
|
|
|
|
b'quamous cell carcinoma of skin or treated cervical carcinoma in situ. Cancer treated with'
|
|
|
|
|
b'curative intent \\u2265 5 years previously will be allowed. Cancer treated with curative intent <'
|
|
|
|
|
b'5 years previously will not be allowed.'
|
|
|
|