Clinical trial NCT02802267 (phase 2, status: unknown status)
Conditions: acute myelogenous leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: inecalcitol, placebo oral tablet
SMILES: [H][C@@]1(CC[C@]2([H])\C(CCC[C@]12C)=C\C=C1C[C@@H](O)C[C@H](O)C1)[C@H](C)CC#CC(C)(C)O, CC1=CC(O)=CC(C)=C1Cl
Eligibility criteria:

        Inclusion Criteria:

        • Patients aged 65 to < 75 years with at least one non severe comorbidity ie disease or
        syndrome with mild to moderate clinical or diagnostic observations or lab abnormalities
        which could increase the risk of toxicity and/or early death of intensive chemotherapy in
        the opinion of the investigator and are not contra-indicated for non-intensive
        chemotherapy.

        or ≥ 75 years with or without any comorbidity at the time of the informed consent
        signature;

        • Newly diagnosed, untreated de novo or secondary AML according to WHO classification;

        Exclusion Criteria:

          -  Prior or current treatment with chemotherapy for any myeloid disorder (excluding
             hydroxyurea) or radiotherapy for extramedullary involvement within 2 weeks of
             randomization;

          -  Prior treatment with decitabine, azacitidine, or cytarabine;

          -  Prior malignancies for 5 years with exception of basal cell, squamous cell carcinoma
             of the skin, or carcinoma " in situ " of the cervix or breast;

          -  Chronic myelogenous or acute promyelocytic leukaemia;

          -  Known CNS involvement;

          -  Patient eligible to bone marrow or stem cell transplant;

          -  WBC ≥ 30.000/mm3;

          -  Impaired renal function with Creatinine clearance < 30 mL/min/1.73m² according to the
             MDRD formula;

          -  Serum bilirubin ≥ 2.5 x ULN and/or AST and/or ALT ≥ 2.5 x ULN (upper limit of normal
             value);

          -  Calcemia ≥ 2.65 mmol/L (106 mg/L) at screening assessment (corrected with
             albuminemia);

          -  History of diseases known to be associated with calcium disorders: ongoing
             hyperparathyroidism, sarcoidosis….;

          -  Presence or history of symptomatic kidney stones in the last 5 years;

          -  Hypersensitivity to any of the excipients of decitabine (Potassium dihydrogen
             phosphate (E340) ; Sodium hydroxide (E524) ; Hydrochloric acid (for pH adjustment) or
             to the excipient of inecalcitol tablets (lactose);

          -  Current use of drugs known to influence serum calcium (such as thiazide diuretics,
             teriparatide, calcitonin and multivitamin supplements containing > 400 IU of vitamin D
             or calcium);

          -  Current use of digitalis;

          -  Current use of drugs which could influence bioavailability of inecalcitol (such as
             magnesium-containing antacids, bile-resin binders);

          -  Use of any other experimental drug or therapy or vitamin D supplementation within 4
             weeks of randomization;

          -  Known HIV;

          -  Patients who are eligible for intensive induction therapy with curative intent;

          -  Refractory congestive heart failure;

          -  Active infection resistant to anti-infective therapy;

          -  Documented pulmonary disease with DLCO ≤ 65% or FEV1≤ 65%, or dyspnea at rest or
             requiring oxygen, or any pleural neoplasm or uncontrolled lung neoplasm;

          -  Liver cirrhosis Child B or C or acute viral hepatitis;

          -  Current mental illness requiring psychiatric hospitalization, institutionalization or
             intensive outpatient management, or current cognitive status that produces dependence
             (as confirmed by the specialist) not controlled by the caregiver;

          -  Uncontrolled neoplasia;