NCT02949570Unknown2 期
Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
Hybrigenics Corporation1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Measure the proportion of responders
研究概览
简要总结
To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.
详细描述
To determine:
- Duration of response
- Progression free survival
- Proportion of responders 2 years after discontinuation of inecalcitol
- Duration of response after discontinuation of inecalcitol and imatinib
- Bone remodelling effect
- Safety of inecalcitol in combination with imatinib
- Quality of Life
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 or 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;
排除标准
- •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;
研究组 & 干预措施
Treatment
Experimental
干预措施: Inecalcitol (Drug)
结局指标
主要结局
Measure the proportion of responders
时间窗: 12 months
Proportion of responder defined as patients achieving MR4.5 (i.e. detectable disease ≤ 0.0032 % BCR-ABLIS or undetectable disease with cDNA with ≥32,000 ABL1 transcripts) at any time within 12 months after the initiation of inecalcitol.
次要结局
未报告次要终点
研究者
研究点 (1)
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