Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) with Newly Diagnosed AML Eligible for Allo-SCT

Más betegség

• Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. • Participation in another clinical trial within 1 month before the start of this trial

Laborértékek

• • Previous treatment for AML (Hydroxyurea is allowed) or for an antecedent Myelodysplastic Syndrome (MDS).
  • Absence of informed consent
  • AML patients with t(15;17); t(8;21); inv(16)
  • Subject has known active CNS involvement with AML.
  • Low Risk ELN
  • grade \>2 NCI-CTCAE (v. 5) adverse events at the time of enrollment
  • 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.
  • The evidence of HBV or HCV active infection (HBV DNA HCV RNA positive test).
  • Patients with HIV infection
  • Current uncontrolled infections
  • Patients with other life-threatening concurrent disease
  • Subjects with known hypersensitivity to any of the component medication
  • Subject has a history of other malignancies within 2 years prior to study entry, with the exception of:

Egyéb

• Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
• Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;

• • Patients \>60 \<75 years of age
  • Diagnosis of AML eligible for allo-SCT from any donor
  • High- and Intermediate-Risk ELN
  • WBC \<25x109/L (Hydroxyurea is permitted to meet this criterion)
  • adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL)
  • adequate renal function (creatinine clearance ≥50 ml/min)
  • ECOG Performance Status \< 2
  • Males enrolled in the study with partners who are women of childbearing potential, must be willing to use an acceptable barrier contraceptive method during the trial.
  • Women of childbearing potential must use highly effective contraception for at least 1 month after the last dose of VEN and for however long the EU SmPC says for DEC
  • Willing and able to comply with all of the requirements and visits in the protocol.
  • Written and signed informed consent.