Efficacy Study of Inecalcitol in Combination with Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

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. (examples provided in section 5.3)
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;
•Fertile men agree to practice effective contraception during the study and for 3 months following treatment discontinuation;
•Patients agree to comply with the study requirements and agrees to come to the clinic for required study visits;
•Patients agree to follow medication restrictions during the study;
•Patients have signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

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;
•Chronic myelogenous or acute promyelocytic leukaemia;
•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;
•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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