NCT02802267Unknown2 期
Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
Hybrigenics Corporation8 个研究点 分布在 2 个国家目标入组 110 人开始时间: 2016年6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
- 110
- 试验地点
- 8
- 主要终点
- overall survival
研究概览
简要总结
Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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;
研究组 & 干预措施
inecalcitol
Experimental
Two tablets of Inecalcitol 2mg each (total 4mg) taken orally every other day.
干预措施: Inecalcitol (Drug)
placebo
Placebo Comparator
Two tablets of placebo 2mg each (total 4mg) taken orally every other day
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
overall survival
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (8)
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