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

NCT03715621 | Unknown

• 1 other identifier: AML-NGS-2018
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 1-year relapse rate after allo-HSCT

  1-year relapse rate after allo-HSCT

  1 year after allo-HSCT

Secondary Outcomes (2)

• 1-year recurrence-free survival (RFS)

  1 year after allo-HSCT

• 1-year overall survival (OS)

  1 year after allo-HSCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects with the diagnosis of AML who is going to receive an allo-geneic HSCT within 30 days

You may qualify if:

• 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.

You may not qualify if:

• Active malignancy;
• Pregnant or breast feeding women.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First affiliated Hospital of SooChow University

Suzhou, Jiangsu, 215006, China

Location

Related Publications (25)

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MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Depei Wu, doctor

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Zhang, master

CONTACT

8613382108261; lcsy2013@sina.com

Yang Xuyang, doctor

CONTACT

8613732628683; xuyang1020@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 23, 2018
• Study Start: October 15, 2018
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2021
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

CN (1)