NCT00124748终止3 期
A Randomized Open-label Study of 400 mg Versus 800 mg of Imatinib Mesylate in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 476
- 试验地点
- 49
- 主要终点
- Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months
研究概览
简要总结
This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis)
- •Diagnosis of chronic myelogenous leukemia (CML) in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Breakpoint cluster region gene-abelson proto-oncogene (Bcr-Abl)
- •Documented chronic phase CML
- •Adequate end organ function as defined by:
- •total bilirubin < 1.5 x Upper Limit of Normal (ULN)
- •Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x ULN
- •creatinine < 1.5 x ULN
排除标准
- •Patients in late chronic phase, accelerated phase, or blastic phase are excluded
- •Patients who have received other investigational agents
- •Patients who received Gleevec/Glivec for any duration prior to study entry, with the exception of those patients successfully completing [CSTI571A2107 (NCT00428909)] study immediately prior to the participation in this study
- •Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
- •Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
- •Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- •Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes,chronic renal disease)
- •Patient previously received radiotherapy to ≥ 25% of the bone marrow
- •Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
- •Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score ≥ 3
- •Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
- •Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required
- •Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment
- •Other protocol-defined inclusion/exclusion criteria applied.
研究组 & 干预措施
Imatinib 400 mg
Experimental
Oral dose of 400mg Imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
干预措施: Imatinib mesylate (Drug)
imatinib 800 mg
Experimental
Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
干预措施: Imatinib mesylate (Drug)
结局指标
主要结局
Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months
时间窗: 12 months
MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region \[Bcr\] gene and Abelson proto-oncogene \[Abl\] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction \[RT-PCR\] (performed centrally).
次要结局
- Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months(24, 36 and 42 months)
- Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months(12, 24, 36, 42 months)
- Percentage of Participants With Complete Hematological Response (CHR) Rates at 12, 24, 36, and 42 Months(12, 24, 36, and 42 months)
- Percentage of Patients With Undetectable Levels of Bcr-Abl (A Fusion Gene of the Breakpoint Cluster Region [Bcr] Gene and Abelson Proto-oncogene [Abl] Genes) Transcripts(12 , 24, 36 and 42 months)
- Time to First Major Molecular Response(42 months overall)
- Time to First Complete Cytogenetic Response(60 months overall)
- Time to First Complete Hematological Response (CHR)](60 months overall)
- Estimated Rate of Event Free Survival (EFS) in Two Treatment Arms(60 months over all)
- Estimated Rate of Progression Free Survival (PFS) in Two Treatment Arms(60 months over all and follow up period)
- Estimated Rate of Progression to Accelerated Phase (AC)/Blast Crisis (BC) in Two Treatment Arms(60 months over all and follow up period)
- Estimated Rate of Overall Survival (OS) in Two Treatment Arms(60 months over all and follow up period)
- Kaplan-Meier Estimates of Duration of First Major Molecular Response Until Confirmed Loss(From First major molecular response to first confirmed loss or censoring)
- Kaplan-Meier Estimates of Duration of First Complete Cytogenetic Response (CCyR)(From first complete cytogenetic response to first confirmed loss or censoring)
- Mean Actual Dose Intensity Per Day(start of treatment to Month 36)
- Imatinib Pharmacokinetic Trough Plasma Concentration (Cmin) at Month 12(Month 12)
- Estimated Rates of Progression Free Survival (PFS) on Treatment by Major Molecular Response (MMR)(42 months)
- Time to First Complete Molecular Response (CMR)](48 months overall)
- Number of Participants With the Effect of Imatinib on the Diabetic Participants With Known Concomitant Type II Diabetes(12 months)
研究者
研究点 (49)
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