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临床试验/NL-OMON37795
NL-OMON37795已完成4 期

Validation of digital-PCR analysis through programmed imatinib interruption in PCR negative chronic myeloid leukemia patients. - ISAV

niversity of Milano-Bicocca0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
5

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • 1. Signed and dated IRB/IEC-approved Informed Consent. 2. Age >/= 18 years. 3. 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. 4. Sustained Complete Molecular Response (as defined by the treating center) for at least 18 months with imatinib treatment. 5. A minimum of 3 CMR determined by Q-RT-PCR analysis to support disease status, with the least one performed within 3 calendar months prior to enrollment date. 6. Willingness and ability to comply with scheduled visits, laboratory tests and other study procedures.

排除标准

  • 1. Allogenic hematopoietic stem cell transplantation. 2. Known active infections, including human immunodeficiency virus (HIV) positivity. 3. Current enrollment in another clinical trial. 4. 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.

研究者

发起方
niversity of Milano-Bicocca

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Validation of digital-PCR analysis through... | 临床试验