Patients with high risk AML non eligible for an intensive treatment and for an allogeneic transplantation will be treated with azacitidine and venetoclax. The fourth, fifth and sixth injection of azacitidine will be followed by injection of haplo-identical lymphocytes (HLI). This is a single-center phase I study to identify the dose of HLI with the most tolerable toxicity. TheBayesian continuous reassessment method (CRM) will be used
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
the patients will receive the injection of donor lymphocytes from haplo-identical donor (the son or daughter or possibly nephew or niece of the patient). No immunosuppressive drugs will be used. The HLI dose levels are 1) 1x107 CD3+/kg 2) 5x107 CD3+/kg 3) 7.5x107 CD3+/kg 4) 1x108 CD3+/kg.The CRM method (Continual Reassessment Method) was chosen to specify the dose of cells to be injected, each patient being assigned a dose that is believed to be associated with the target toxicity corresponding to the maximum tolerated dose (MTD). The dose-toxicity curve will be readjusted after assessing the toxicity of each patient.
CHU de Nantes
Nantes, France
RECRUITINGnumber of DLT
Time frame: by day 14
cumulative incidence of relapse
Time frame: 1 YEAR
relapse-free survival
Time frame: 1 YEAR
overall survival
Time frame: 1 YEAR
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