Clinical trial NCT02758080: Matching Patients With Hematologic Malignancy to Adequate Clinical Trials
Official title: Pragmatic Clinical Trial of Matching Malignant Hematologic Cancer Patients With Adequate Early Phase Clinical Trials by Next-generation Sequencing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Malignancies
Keywords: Personalized medicine
Next generation sequencing
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: The Korea Health Technology R&D Project through the Korea Health Industry Development Institute
name: Ministry of Health, Republic of Korea
First posted: 2016-05-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate
timeFrame: one year
Secondary outcomes:
measure: Types of identified molecular profile
timeFrame: one year
measure: Overall survival
timeFrame: one year
measure: Progression-free survival
timeFrame: one year
measure: Toxicity profile
timeFrame: one year
measure: Frequencies of identified molecular profile
timeFrame: one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youngil Koh, MD
role: PRINCIPAL_INVESTIGATOR
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