Clincosm LogoSign in Get a demo

Matching Patients With Hematologic Malignancy to Adequate Clinical Trials

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02758080
Collaborator
The Korea Health Technology R&D Project through the Korea Health Industry Development Institute (Other), Ministry of Health, Republic of Korea (Other)
90
Enrollment
1
Location
2
Arms
41
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Matching on the basis of molecular analysis
  • Other: Matching on the basis of physician's choice
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pragmatic Clinical Trial of Matching Malignant Hematologic Cancer Patients With Adequate Early Phase Clinical Trials by Next-generation Sequencing
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Matched

A molecular profile is identified using next generation sequencing. A participant in this arm is assigned to early clinical trial studying targeted agent, which is anticipated to have the best response rate.

Other: Matching on the basis of molecular analysis
Other: Not matched

A participants in this arm is assigned to a clinical trial at physician's choice.

Other: Matching on the basis of physician's choice

Outcome Measures

Primary Outcome Measures

  1. Response rate [one year]

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

Secondary Outcome Measures

  1. Types of identified molecular profile [one year]

  2. Overall survival [one year]

  3. Progression-free survival [one year]

  4. Toxicity profile [one year]

    according to CTCAE version 4.0

  5. Frequencies of identified molecular profile [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Youngil Koh, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Youngil Koh, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02758080
Other Study ID Numbers:
  • 2015-1690
First Posted:
May 2, 2016
Last Update Posted:
Oct 26, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Youngil Koh, Assistant professor, Seoul National University Hospital
Personalized medicine
Next generation sequencing
Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms

Study Results

No Results Posted as of Oct 26, 2017