NCT02096289已完成1 期
A Phase I Trial Evaluating Oral Thioridazine in Combination With Intermediate Dose Cytarabine in Patients 55 Years and Older With Acute Myeloid Leukemia Who Have Relapsed or Have Refractory Disease
Ontario Clinical Oncology Group (OCOG)1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This is a Phase I trial investigating the safety of using thioridazine in addition to cytarabine in elderly patients with relapsed or refractory Acute Myeloid Leukemia.
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
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of AML according to the WHO Classification1
- •AML is refractory or relapsed (requiring at least 5% leukemic blasts in the bone marrow, regardless of the presence of other features such as new or recurrent dysplastic changes or extra medullary disease) according to the following definitions:
- •Relapsed (defined as ≥ 5% leukemic blasts in the bone marrow) after three months from receiving up to three prior induction regimens.
- •Refractory (defined as ≥ 5% leukemic blasts in the bone marrow) to not more than one prior induction regimen (defined as failure to achieve a CR or CRi following induction therapy).
- •55 years of age or older.
排除标准
- •Receiving any other systemic anti-leukemic therapy (standard or investigational).
- •Having received more than two prior chemotherapy lines for AML. Induction/consolidation therapy and bone marrow transplant are each considered a line of therapy.
- •Having received previous AML therapy within four weeks of the first dose of study drug, with the exception of hydroxyurea.
- •Clinical evidence suggestive of CNS involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the CSF.
- •Acute promyelocytic leukemia.
- •An ECOG performance status of 3 or more.
- •Inadequate renal function (i.e., estimated GFR < 60 mL/min/1.73m2).
- •Inadequate hepatic function (i.e., serum bilirubin > 1.5×ULN; AST, ALT and alkaline phosphatase > 2.5×ULN).
- •Presence of acute or chronic GVHD.
- •Presence of a systemic fungal, bacterial, viral or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- •Having any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo induction therapy.
- •Diagnosed with a condition that can prolong the QT interval (e.g., long QT syndrome) or have a QTc interval ≥ 470ms if male, or ≥ 480ms if female.
- •Left ventricular ejection fraction less than 45%.
- •History of uncontrolled cardiac arrhythmia.
- •Known severe hypotensive or hypertensive heart disease.
- •Prior malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values if hormonal therapy has been initiated or a radical prostatectomy has been performed.
- •Known HIV positivity.
- •Known pregnancy or lactating female.
- •Presence of a psychiatric disorder that would interfere with consent, study participation, or follow-up.
- •Unable to provide informed consent.
研究组 & 干预措施
Thioridazine
Experimental
Up to 3 dose levels of thioridazine will be assessed sequentially: 25 mg Q6H (Level I), 50 mg Q6H (Level II) and 100 mg Q6H (Level III). The duration of thioridazine therapy is for a total of 21 days (Days 1-22 on study). All patients will receive cytarabine 1 g/m2 administered as a 2 hour infusion for 5 consecutive days (Days 6-10 on study).
干预措施: Thioridazine (Drug)
结局指标
主要结局
Safety
时间窗: Up to 36 days
Both acute and late toxicities will be determined according to NCI-CTCAE version 4.03
次要结局
- Pharmacokinetic Analysis of Thioridazine Serum Trough Levels(Up to 36 days)
- Assessment of Objective Tumor Response(Up to 36 days)
- Assessment of Functional Leukemia Stem Cells(Up to 36 days)
- Pharmacogenetic Analysis of Thioridazine Serum Trough Levels(Up to 36 days)
研究者
研究点 (1)
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