Safety and Efficacy of FT14 Conditioning for Allogeneic HSCT in Acute Myeloid Leukemia

Korábbi kezelés

• Patients with other life-threatening concurrent diseases
• Participation in another clinical trial within 1 month before the start of this trial

Más betegség

• The evidence of HBV or HCV active infection (HBV DNA, HCV RNA positive test).
• Patients with HIV infection
• Current uncontrolled infections
• Subjects with known hypersensitivity to any of the component medications

Laborértékek

• Serious organ dysfunction: left ventricular ejection fraction < 40%, FEV1, FVC, DLCO (diffusion capacity) <40% of predicted, LFT > 5 times the upper limit of normal, or creatinine clearance < 40 ml/min.

Életkor

• Participant, both female and male, in childbearing age who do not agree to maintain an active contraceptive practice

Egyéb

• AML patients with t(15;17); t(8;21); inv(16)
• Subject has known active CNS involvement with AML.
• Grade >2 NCI-CTCAE (v. 5) adverse events at the time of enrollment
• Pregnant or breastfeeding patients during screening

• Patients >40 <65 years of age
• Diagnosis of AML in first complete remission (CR)/complete remission with incomplete recovery (CRi)/multiflow leukemia free state (MLFS)
• Eligible for allo-SCT from HLA-identical matched related or unrelated donor as defined by molecular high-resolution typing (4 digits) at the following four HLA gene loci (HLA-A, B, C, and DRB1)
• Adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL)
• Adequate renal function (creatinine clearance ≥50 mL/min)
• ECOG Performance Status < 2
• Willing and able to comply with all of the requirements and visits in the protocol.
• Written and signed informed consent