Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT

Acute Myeloid Leukemia Clinical Trial

Official title:

A Study of Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03715621
• Other study ID #: AML-NGS-2018
• Status: Not yet recruiting
• Start date: October 15, 2018
• Est. completion date: October 15, 2021

Study information

• Verified date: October 2018
• Source: The First Affiliated Hospital of Soochow University
• Contact: Xiang Zhang, master
• Phone: 8613382108261
• Email: lcsy2013[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Acute myeloid leukemia (AML) is a genetically heterogeneous disease and allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment option for AML except for AML-M3. Relapse remains the major cause of treatment failure after allo-HSCT. Molecular residual disease has been shown to be a strong risk factor for relapse after HSCT. In this study, the investigators will detect mutations before/after allo-HSCT by using next-generation sequencing (NGS) technique to measure residual disease and evaluate the prognostic impact of molecular residual disease in a cohort of AML participants receiving allo-HSCT.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or old;

• Clinical diagnosis of acute myeloid leukemia (AML);

• Availabe records of MICM and NGS results at diagnosis;

• Be going to receive allo-HSCT.

Exclusion Criteria:

• Active malignancy;

• Pregnant or breast feeding women.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
China	The First affiliated Hospital of SooChow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year relapse rate after allo-HSCT	1-year relapse rate after allo-HSCT	1 year after allo-HSCT
Secondary	1-year recurrence-free survival (RFS)	1-year recurrence-free survival for AML participants	1 year after allo-HSCT
Secondary	1-year overall survival (OS)	1-year overall survival (OS) for AML participants	1 year after allo-HSCT