NCT01227135Unknown2 期
CHOICES: A Randomized Phase II Trial of Imatinib (IM) Versus Hydroxychloroquine (HCQ) and IM for Patients With Chronic Myeloid Leukemia (CML) in Major Cytogenetic Response (MCyR) With Residual Disease Detectable by Quantitative Polymerase Chain Reaction (Q-PCR).
Lynn McMahon6 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2010年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Proportion of treatment "successes" defined as patients who have at least 0.5 log reductions or more in their 12-month PCR level from baseline
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as hydroxychloroquine, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether imatinib mesylate is more effective when given with or without hydroxychloroquine in treating patients with chronic myeloid leukemia.
PURPOSE: This randomized phase II trial is studying the side effects of giving imatinib mesylate with or without hydroxychloroquine and to see how well it works in treating patients with chronic myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- To determine if imatinib mesylate versus hydroxychloroquine (HCQ) and imatinib mesylate is more effective in terms of BCR/ABL levels in patients with chronic myeloid leukemia in major cytogenetic response (MCyR) with residual BCR/ABL-positive cells detectable by quantitative polymerase chain reaction after at least one year of imatinib mesylate treatment.
- To determine the safety and tolerability of this regimen in these patients.
Secondary
- To determine whether the introduction of HCQ influences imatinib mesylate plasma levels.
- To determine if whole blood HCQ levels achieved in combination with imatinib mesylate are in the expected range.
- To determine if HCQ inhibits autophagy in vivo.
- To evaluate the effects of this regimen on residual BCR/ABL-positive primitive progenitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of chronic myeloid leukemia (CML) in chronic phase (CP)
- •Has been treated with imatinib mesylate for at least 1 year
- •Receiving a stable dose for ≥ 6 months prior to randomization
- •Achieved at least major cytogenetic response (MCyR) and continues to be BCR/ABL-positive by quantitative polymerase chain reaction (Q-PCR)
- •Must have a fusion gene present that can be monitored by Q-PCR
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm³ (stable and within normal range for ≥ 2 months)
- •Platelet count ≥ 100,000/mm³ (stable and within normal range for ≥ 2 months)
- •Serum albumin > 3 g/dL
- •AST and/or ALT ≤ 2.5 times upper limit of normal (ULN)
- •Serum bilirubin ≤ 1.5 times ULN
- •Serum creatinine ≤ 1.5 times ULN OR 24-hour creatinine clearance ≥ 50 mL/min
- •Serum potassium ≥ lower limit of normal with or without replacement therapy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double-method contraception (including a barrier method [i.e., condom]) during and for 3 months after completion of study therapy
- •No impaired cardiac function, including any of the following:
- •QTc > 450 msec on screening ECG
- •Congenital long QT syndrome
- •History or presence of sustained ventricular tachycardia
- •History of ventricular fibrillation or Torsades de pointes
- •NYHA class III-IV congestive heart failure
- •Uncontrolled hypertension
- •No severe gastrointestinal (GI) disorder, uncontrolled epilepsy, known glucose-6-phosphate dehydrogenase (G6PD) deficiency, known porphyria, moderate or severe psoriasis, known myasthenia gravis, or other concurrent severe and/or uncontrolled medical conditions
- •No preexisting maculopathy of the eye
- •No significant history of noncompliance to medical regimens or the inability to grant a reliable informed consent
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy, investigational drug, or major surgery and recovered
- •More than 6 months since change in imatinib mesylate dose
- •No other concurrent anticancer therapy or radiotherapy
排除标准
- 未提供
结局指标
主要结局
Proportion of treatment "successes" defined as patients who have at least 0.5 log reductions or more in their 12-month PCR level from baseline
次要结局
- Proportion of treatment "successes" at 24 months
- Molecular response at 12 and 24 months (complete response, major response, or no response)
- Proportion of patients with progression at 12 and 24 months
研究者
Lynn McMahon
Project Manager
University of Glasgow
研究点 (6)
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