Exploratory Study of Inecalcitol in Imatinib-TreatedResidual Chronic Myeloid Leukaemia: INIM Study - INIM study

Hybrigenics SA0 个研究点目标入组 54 人开始时间: 2015年6月19日最近更新: 2018年7月23日

适应症

试验速览

暂无简介。

•Men or women aged of at least 18 years at the time of informed consent signature;
•Patients have signed written informed consent;
•ECOG performance status < 2;
•Patients with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity (e13a2 ou e14a2);
•Treatment with imatinib for more than 2 years (a history of treatment with interferon is tolerated);
•Patient in complete cytogenetic response with BCR-ABL/ABL status between 0.1% International Scale (IS) and 0.01% IS and no BCR-ABL checkpoint in the last six months better than Molecular Response MR4 (i.e. BCR-ABL ratio < 0.01% IS);
•Women of child bearing potential have a negative pregnancy test prior to first dose and agree to practice effective contraception during the study;
•Fertile men agree to practice effective contraception during the study;
•Patients agree to comply with the study requirements and agree to come to the clinic for required study visits;
•Patients agree to follow medication restrictions during the study;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 54
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 54

•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 from 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, bisphosphonates, and 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;

发起方

Hybrigenics SA