Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study

Exclusion Criteria

• •Expression of unusual BCR-ABL transcripts (other than e13a2 or e14a2);
• •Pregnant or lactating women;
• •Participating in another clinical trial with any investigative drug within 30 days prior to study enrolment(except for OPTIM imatinib);
• •Treatment with interferon within the last 24 months;
• •Imatinib dose modification within the last 3 months;
• •Prior history of haematopoietic stem cell transplantation;
• •Impaired renal function with creatinine clearance \< 30 ml/min/1.73m² according to the MDRD formula;
• •Hypercalcemia (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;
• •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);
• •Patients with a chronic condition which is not well controlled that, according to the investigator, would interfere with the completion of the study;
• •Use of any other experimental drug, therapy or vitamin D supplementation within 30 days of first inecalcitol administration;
• •Patients with a mental deficiency preventing proper understanding of trial protocol requirements;