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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03715621

Enrollment

500

Registered

2018-10-23

Start date

2018-10-15

Completion date

2021-10-15

Last updated

2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, next generation sequencing, Hematopoietic Stem Cell Transplantation

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
1-year relapse rate after allo-HSCT	1 year after allo-HSCT	1-year relapse rate after allo-HSCT

Secondary

Measure	Time frame	Description
1-year recurrence-free survival (RFS)	1 year after allo-HSCT	1-year recurrence-free survival for AML participants
1-year overall survival (OS)	1 year after allo-HSCT	1-year overall survival (OS) for AML participants

Countries

China

Contacts

Primary ContactXiang Zhang, master

lcsy2013@sina.com8613382108261

Backup ContactYang Xuyang, doctor

xuyang1020@126.com8613732628683

Outcome results