Matching Patients With Hematologic Malignancy to Adequate Clinical Trials

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02758080
• Other study ID #: 2015-1690
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2016
• Last updated: October 24, 2017
• Start date: January 2016
• Est. completion date: June 2019

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: Ryul Kim, MD
• Phone: +82 10 9412 6108
• Email: chrono0707[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancies
• Neoplasms

Intervention

Other:
• Matching on the basis of molecular analysis

• Matching on the basis of physician's choice

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

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

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

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Kwak EL, Bang YJ, Camidge DR, Shaw AT, Solomon B, Maki RG, Ou SH, Dezube BJ, Jänne PA, Costa DB, Varella-Garcia M, Kim WH, Lynch TJ, Fidias P, Stubbs H, Engelman JA, Sequist LV, Tan W, Gandhi L, Mino-Kenudson M, Wei GC, Shreeve SM, Ratain MJ, Settleman J, Christensen JG, Haber DA, Wilner K, Salgia R, Shapiro GI, Clark JW, Iafrate AJ. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010 Oct 28;363(18):1693-703. doi: 10.1056/NEJMoa1006448. Erratum in: N Engl J Med. 2011 Feb 10;364(6):588. — View Citation

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* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Response evaluation is based on the criteria suggested in a clinical trial to which a participant is assigned.	one year
Secondary	Types of identified molecular profile		one year
Secondary	Overall survival		one year
Secondary	Progression-free survival		one year
Secondary	Toxicity profile	according to CTCAE version 4.0	one year
Secondary	Frequencies of identified molecular profile		one year