Matching Patients With Hematologic Malignancy to Adequate Clinical Trials

Not Applicable

• Conditions: Hematologic Malignancies
• Interventions: Other: Matching on the basis of physician's choice; Other: Matching on the basis of molecular analysis

• Registration Number: NCT02758080
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-05-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Not matched	Matching on the basis of physician's choice	A participants in this arm is assigned to a clinical trial at physician's choice.
Matched	Matching on the basis of molecular analysis	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall survival	one year
Toxicity profile	one year	according to CTCAE version 4.0
Progression-free survival	one year
Types of identified molecular profile	one year
Frequencies of identified molecular profile	one year

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of