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Matching Patients With Hematologic Malignancy to Adequate Clinical Trials

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02758080
Enrollment
90
Registered
2016-05-02
Start date
2016-01-31
Completion date
2019-06-30
Last updated
2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancies

Keywords

Personalized medicine, Next generation sequencing

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.

Interventions

OTHERMatching on the basis of molecular analysis
OTHERMatching on the basis of physician's choice

Sponsors

The Korea Health Technology R&D Project through the Korea Health Industry Development Institute
CollaboratorUNKNOWN
Ministry of Health, Republic of Korea
CollaboratorOTHER_GOV
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Response rateone yearResponse evaluation is based on the criteria suggested in a clinical trial to which a participant is assigned.

Secondary

MeasureTime frameDescription
Types of identified molecular profileone year
Overall survivalone year
Progression-free survivalone year
Toxicity profileone yearaccording to CTCAE version 4.0
Frequencies of identified molecular profileone year

Countries

South Korea

Contacts

Primary ContactRyul Kim, MD
chrono0707@icloud.com+82 10 9412 6108

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026