ISRCTN60655195已完成3 期
A phase 3 randomised non-inferiority trial to evaluate the most effective way to use imatinib, nilotinib and ponatinib in patients with newly-diagnosed chronic phase chronic myeloid leukaemia
ewcastle-upon-Tyne Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 1,000 人开始时间: 2013年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female patients who are 18 years of age or over.
- •2. Patients must fulfill all of the following:
- •2.1. Be diagnosed with chronic phase chronic myelogenous leukemia (CML) confirmed by blood morphology and reverse transcriptase polymerase chain reaction (RT-PCR) for BCR-ABL.
- •2.2. Be enrolled within 3 months of initial diagnosis of chronic phase CML (date of RT-PCR confirming presence of BCR-ABL)
- •2.3. Be in confirmed chronic phase ie:
- •2.3.1. Less than 15% blasts in blood (manual differential)
- •2.3.2. Less than 30% blasts plus promyelocytes in blood
- •2.3.3. Less than 20 % basophils in blood
- •2.3.4. Less than 100 x 109 /L platelets
- •2.3.5. No evidence of extramedullary leukaemic involvement, with the exception of hepatosplenomegaly
- •3. Written voluntary informed consent.
排除标准
- •1. Any prior treatment for CML with any tyrosine kinase inhibitors (TKI) (eg imatinib, dasatinib, nilotinib, bosutinib, ponatinib); busulphan, interferon-alpha (IFN-alpha), homoharringtonine, cytosine arabinoside, any other investigational agents.
- •2. Patients who have received prior CML chemotherapy including regimens used in peripheral blood progenitor cells (PBPCs) mobilisation for haematopoietic progenitor-cell transplantation. (collection of unmobilised PBPCs is allowed at diagnosis).
- •3. Patients who have had any form of prior haematopoietic stem cell transplant (autograft or allograft).
- •4. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score = 3
- •5. Patients with serum bilirubin, SGOT/AST, SGPT/ALT or creatinine concentrations > 2.0 x upper limit of normal (ULN)
- •6. Patients with serum amylase or lipase > 1.5 x ULN, history of acute pancreatitis within 1 year of study, history of chronic pancreatitis, or uncontrolled hypertriglyceridaemia (triglycerides > 450 mg/dL)
- •7. Patients with significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to a) myocardial infarction, unstable angina and/or congestive heart failure within 6 months prior to study; and b) history of clinically significant atrial arrhythmia; or any ventricular arrhythmia.
- •8. Patients taking medications known to be associated with Torsade de Pointes (eg amiodarone, azithromycin, chloroquine, citalopram, domperidone, erythromycin, quinidine, sotalol, thioridazine)
- •9. Patients with known uncontrolled hypertension; systolic blood pressure > 140mm Hg and/or diastolic blood pressure > 90mm Hg
- •10. Patients with a known international normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants, or patients with a known bleeding disorder. Baseline testing of INR is not required.
- •11. Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders or infection.
- •12. Patients who have undergone major surgery within 4 weeks of starting trial investigational medicinal products (IMP).
- •13. Patients who are:
- •13.1. Pregnant
- •13.2. Breast feeding
- •13.3. Of childbearing potential without a negative pregnancy test prior to starting trial IMP
- •13.4. Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential).
- •14. Patients with a history of another malignancy either currently or within the past five years (with the exception of basal cell skin carcinoma in situ).
- •15. Patients with a history of non-compliance to medical regimens or patients who can envisage being unable to complete the study for any reason.
- •16. Patients unwilling to receive trial drug via a home delivery method.
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