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临床试验/CTRI/2018/08/015357
CTRI/2018/08/015357尚未招募未知

TO STUDY THE TREATMENT FREE REMISSION RATE AND THE FACTORS ASSOCIATED WITH IT IN PATIENTS WITH CML WHO ARE ON GENERIC FORMS OF IMATINIB

PGIMER CHANDIGARH0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募

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

入选标准

  • 1.Patients diagnosed with CML-CP who are receiving treatment with Imatinib for at least 3 years of duration and are > 18 years old.
  • 2.The patients must have attained the milestones of disease monitoring as per the recommended guidelines.
  • 3.The patients must be compliant to the treatment with regular follow up and molecular monitoring. (As per data recorded in their respective files)
  • 4.The patients must have molecular response of at least MR 4 (BCR-ABL transcript levels < 0.01), which is sustained for at least 3 years before the imatinib discontinuation is attempted.
  • 5.Patients who are on generic forms of imatinib will be included in the study.
  • 6.Before entering the study the patients should understand the investigational nature of this study, regular follow up as advised and should sign the consent form.

排除标准

  • 1.Patients diagnosed with advanced form of disease CML-AP (Accelerated Phase) and CML-BP (Blast Phase).
  • 2.Patients who are incompliant to the treatment with frequent interruption of medication despite being in sustained molecular response.
  • 3.Patients who are seropositive for HIV, HBsAg and HCV.
  • 4.Patients who have other concomitant disease (connective tissue disorders, second malignancy etc.) will be excluded from the study.
  • 5.Those who do not sign the consent form.

研究者

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