NCT01460693已完成3 期
A Phase III, Prospective Randomised Comparison of Imatinib (STI571, Glivec/Gleevec) 400mg Daily Versus Dasatinib 100mg in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 814
- 试验地点
- 1
- 主要终点
- 5-year event free survival
研究概览
简要总结
Imatinib 400mg daily is the current NICE-approved standard treatment for newly diagnosed Chronic Myeloid Leukaemia (CML). 5 yr follow up of CML patients treated in this way indicates an 89% probability of progression-free survival. Imatinib is not tolerated or effective in some patients however, and a proportion of patients become resistant to the drug. SPIRIT 2 study aims to establish whether a new drug, dasatinib, is superior to imatinib in terms of event free survival and therefore will be an effective first-line therapy for newly-diagnosed CML patients. This study will also provide crucial long-term survival, quality of life and health economic data to assist health care providers and managers to determine the most cost-effective drug therapy for CML.
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
- 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
- •Male or female patients 18 years or over.
- •Patients must have all of the following:
- •be enrolled within 3 months of initial diagnosis of CML-CP (date of initial diagnosis is the date of first cytogenetic analysis)
- •cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations
- •patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome.
- •< 15% blasts in peripheral blood and bone marrow;
- •< 30% blasts plus promyelocytes in peripheral blood and bone marrow;
- •< 20% basophils in peripheral blood,
- •100 x 109/L platelets or greater
- •no evidence of extramedullary leukaemic involvement, with the exception of the hepatosplenomegaly.
- •Written voluntary informed consent.
排除标准
- •Patients with Ph-negative, BCR-ABL-positive, disease are NOT eligible for the study.
- •Any prior treatment for CML with: any tyrosine kinase inhibitor (eg imatinib, dasatinib); busulphan; interferon-alpha; homoharringtonine; cytosine arabinoside; any other investigational agents (hydroxycarbamide and anagrelide are the only drugs permitted). NB patients will be ineligible for the study if they have received ANY prior therapy with interferon-alpha or imatinib. NO exceptions.
- •Patients who received prior chemotherapy, including regimens used in peripheral blood progenitor cells (PBPCs) mobilisation for haematopoietic progenitor-cell transplantation. (It is allowable to collect unmobilised PBPCs at diagnosis.)
- •Patient who have had any form of prior haemopoietic stem cell transplant, either autograft or allograft.
- •Patients with an ECOG Performance Status Score of 2 or less.
- •Patients with serum bilirubin, SGOT/AST, SGPT/ALT, or creatinine concentrations > 2.0 x the institutional upper limit of the normal range (IULN).
- •Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x IULN, with the exception of patients on treatment with oral anticoagulants.
- •Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina, or Grade 3/4 cardiac problems as defined by the New York Heart Association Criteria.
- •Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required.
- •Patients who have undergone major surgery within 4 weeks of Study Day 1, or who have not recovered from prior major surgery.
- •Patients who are:
- •pregnant,
- •breast feeding,
- •of childbearing potential without a negative pregnancy test prior to Study Day 1, and
- •male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- •Patients with a history of another malignancy either currently or within the past five years, with the exception of basal cell skin carcinoma or cervical carcinoma in situ.
- •Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
研究组 & 干预措施
Arm A - Imatinib
Active Comparator
Imatinib 400mg daily
干预措施: Imatinib (Drug)
Arm B - Dasatinib
Experimental
Dasatinib 100mg daily
干预措施: Dasatinib (Drug)
结局指标
主要结局
5-year event free survival
时间窗: ongoing throughout study (5 years)
To compare 5-year event free survival between the 2 treatment arms. The study aim is to show superiority of the dasatinib arm over the imatinib 400mg arm.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular ResponseLeukemia, Myeloid, Chronic-PhaseNCT01827930Institut Bergonié68
已完成
2 期
A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate Plasmatic Through Level in Patients Newly Diagnosed With CP-CMLLeukemia, Myelogenous, Chronic, BCR-ABL PositiveNCT02896842Versailles Hospital139
已完成
2 期
Therapy of Early Chronic Phase CML With GleevecLeukemia, Myeloid, Chronic-PhaseNCT00048672M.D. Anderson Cancer Center50
已完成
2 期
Imatinib Mesylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by SurgeryAcral Lentiginous Malignant MelanomaRecurrent MelanomaStage IIIA MelanomaStage IIIB MelanomaStage IIIC MelanomaStage IV MelanomaNCT00470470National Cancer Institute (NCI)30
终止
2 期
Therapy of Early Chronic Phase CML With Higher-Dose Gleevec, Alpha Interferon, and Low-Dose Ara-CMyelogenous Leukemia, Chronic, Chronic PhaseNCT00038649M.D. Anderson Cancer Center117