Clinical Research Directory

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Male or female subjects ≥ 65 years of age at the time of signing the ICD; 2. Diagnosed, histologically confirmed at inclusion, * Int-2 or High according to IPSS, or * Very High, High or Intermediate according to IPSS-R, or * Hypoplastic AML (20-30% BM blasts, previosuly considered MDS RAEB-T) * myelodysplastic CMML (included in IPSS scoring, WBC \< 13.x 109/L); 3. Should have undergone therapy with subcutaneous azacitidine for at least 4-6 cycles ( + 2 cycles) 4. Must have achieved CR/CRi, PR or SD with HI status, as evidenced by IWG Criteria 2006 ( APPENDIX E): 5. ECOG performance status of 0, 1, 2 (Appendix C); 6. Adequate bone marrow function based on ANCs ≥ 1.0 x 109/L and platelet counts ≥ 70 x 109/L. 7. Adequate organ function, defined as: Serum bilirubin ≤1.5 times the upper limit of normal (ULN); Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the ULN; Serum creatinine ≤ 2.5 times the ULN; 8.Male subjects with a female partner of childbearing potential must agree to practice abstinence or to the use of a physician-approved contraceptive method throughout the course of the study and avoid fathering a child during the course of the study and for 3 months following the last dose of azacitidine; 10. Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted; 11. Able to adhere to the study visit schedule and other protocol requirements; 12. Ability to swallow study medication. Exclusion Criteria: * Absence of confirmed hematological response ( IWG HI/PR/CR) after at least 4 to 6 months of azacitidine sc and maintenance of response for 2 additional cycles. * Inability to provide a valid informed consent. * Eligibility for HSCT * Active infection * Serum creatinine \> 2 x ULN at screening. * ECOG performance status \> 2 * Left ventricular ejection fraction \< 50% by echocardiography * A history of repeated hospitalization for severe infections Systemic diseases that would prevent study treatment (e.g. uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.) * Clinical or laboratory evidence of chronic Hepatitis B or Hepatitis C (definition of * chronic hepatitis follows EASL 2017 criteria). * History of HIV positive test result (ELISA or Western blot). * ALT or AST over 3 times superior to ULN at screening. * Total bilirubin over 1.5 times superior to ULN at screening (patients with Gilbert syndrome are allowed to enter the study) * Patients participating in another clinical trial other than an observational registry study. * Patients with a history of another malignancy within the past 3 years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ. * History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative. * Presence of a surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug. * History of drug or alcohol abuse within the 12 months prior to enrollment.