Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients (ISAV)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 14
- 主要终点
- The Negative Predicted Value Ratio (rNPV) of dPCR over Q-RT-PCR
研究概览
简要总结
The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.
详细描述
This study will recruit approximately 100 CML patients under imatinib therapy in complete molecular remission with a history of at least 18 months of consecutive negative standard Q-RT-PCR as performed in their own centers. After signing the informed consent form (ICF), the patients will be tested for dPCR and will discontinue imatinib therapy. Then they will be monitored by standard Q-RT-PCR to assess the maintenance of the molecular remission; collection of data will be prospective as each center will collect the data for 36 months. At the end of this period, a peripheral blood sample for dPCR analysis will be obtained from those patients who will still have undetectable BCR-ABL transcripts by Q-RT-PCR to verify CML eradication. The maintenance of molecular remission by Q-RT-PCR and the survival will be monitored every six months during an additional follow-up of 24 months. Patients found to be positive to BCR-ABL transcripts by standard Q-RTPCR will repeat the test every 2 to 4 weeks until the loss of molecular remission, defined as two consecutive BCR-ABL positive tests with at least one with BCR-ABL/BCR value above 0.1%, or until the end of the study, whichever come first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Signed and dated IRB/IEC-approved Informed Consent
- •Age>=18 years
- •Male or female patients with CML diagnosed in chronic or accelerated phase and who have been treated for more than 2 consecutive years with imatinib therapy
- •Sustained Complete Molecular Response (as defined by the treating center) for at least 18 months with imatinib treatment
- •A minimum of 3 CMR determined by Q-RT-PCR analysis to support disease status, with the list one performed within 3 calendar months prior to enrollment date
- •Willingness and ability to comply with scheduled visits laboratory tests and other study procedures
排除标准
- •Allogenic hematopoietic stem cell transplantation
- •Known active infections including human immunodeficiency virus (HIV) positivity
- •Current enrollment another clinical trial
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results
研究组 & 干预措施
Imatinib
干预措施: Imatinib mesylate (Drug)
结局指标
主要结局
The Negative Predicted Value Ratio (rNPV) of dPCR over Q-RT-PCR
时间窗: At 36 months.
The capability of the dPCR method to predict relapse-free patients relative to the standard method. NPV of each method will be computed as the number of patients who are negative according to either method at the time of imatinib discontinuation and remain relapse-free 36 months later over the total of negative patients according to either method, respectively
次要结局
- Overall Survival(At the end of the study)
- Rate of patients progressing or developing resistance(At 36 months)
- Rate of molecular and cytogenetic relapse(At 36 months)
- Rate of dPCR positive patients(At 36 months)
- Quality of Life Assessment(At 36 months)
- Rate of dPCR negative patients(At 36 months)
- Rate of patients who are maintaining dPCR negativity for 36 months(At 36 months)
- Time to molecular relapse(At 36 months)