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Pragmatic Clinical Trial of Matching Malignant Hematologic Cancer Patients With Adequate Early Phase Clinical Trials by Next-generation Sequencing (NCT02758080)

The Korea Health Technology R&D Project through the Korea Health Industry Development Institute
The Ministry of Health & Welfare, Republic of Korea
A molecular profile of a patient with hematologic malignancy, for whom standard-of-care had failed, is identified using next generation sequencing. Patients are assigned to early clinical trials of targeted agent based on the molecular profiling or physician's choice. The improvement of outcomes in the intention-to-treat population is investigated.
  • Other: Matching on the basis of molecular analysis
    • Other: Matching on the basis of physician's choice
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers
      Inclusion Criteria:
      • adults with > 18 years old
      • incurable hematologic malignancy patients who failed to respond to standard treatment
      • patients who agreed to this protocol with informed consent
      • Eastern Cooperative Oncology Group performance status ≤ 3
      • Tolerable major organ function determined by laboratory examination
      Exclusion Criteria:
      • Expected survival < 3 months
      • patients with poor compliance
      • patients who can not give an informed consent
      • patients who are participating another clinical trials
      Most of hematologic malignancy patient becomes incurable with standard treatment during their disease course. Although these patients are recommended to participate in an early phase clinical trials, the response rate have reported be only 4 to 6 percent. Over several decades, a lot of cancer driving mutations has been identified, and targeted agents directed at the mutations are continuously developed and studied in many clinical trials. Most of the clinical trials recruited participants regardless of mutational status of them. Recently, however, participants has been recruited in recent clinical trials according to the presence of specific mutations. The response rate of these recent clinical trials is 12-75%.

      In this pragmatic clinical trial, cancer driving mutations in hematologic malignancy patients is identified using next generation sequencing, and assign patients to an appropriate clinical trial which is anticipated to exhibit the best response. The improvement of outcome of this biomarker-driven assignment is investigated.

      1 locations

      Korea, Republic of (1)
      • Seoul National University Hospital
        Seoul, Korea, Republic of, 03080
      31 December, 2015
      23 October, 2017
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