Matching Patients With Hematologic Malignancy to Adequate Clinical Trials

Seoul National University

Status: Unknown

Conditions: Hematologic Malignancies

Treatments: Other: Matching on the basis of physician's choice; Other: Matching on the basis of molecular analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02758080

2015-1690

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Matched

Experimental group

Description:

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.

Treatment:

Other: Matching on the basis of molecular analysis

Not matched

Other group

Description:

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

Treatment:

Other: Matching on the basis of physician's choice