Prospective and Retrospective Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and During Treatment or Thereafter in Acute Leukemia (Acute Leukemia HSCT Cohort)

Acute Leukemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02344953
• Other study ID #: 4-2010-0669
• Status: Recruiting
• Start date: January 2011
• Est. completion date: January 2021

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: JUNE-WON CHEONG, MD
• Phone: 82-2-2228-1970
• Email: JWCHONG70[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to evaluate the prognostic factors of acute leukemia patients received stem cell transplantation and to invent the molecular genetic test for sensitive detection of minimal residual disease, and thereby this study would contribute to plan the risk adapted treatment. Patients will have samples of blood and/or bone marrow collected during treatment or thereafter

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with acute leukemia who underwent allo-HSCT in Severance Hospital.

• Both genders of 16 Years and older

• sign a written informed consent document

• exemption of consent in patient who died in study period.

Exclusion Criteria:

• No comprehension or willingness to sign a written informed consent document.

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival (OS) is defined as the time from date of diagnosis until death due to any cause within the follow-up period. Surviving patients are censored at date of last contact.	10years
Secondary	Progression-free survival	Progression-free survival (PFS) is defined as survival without disease progression or relapse; patients alive without disease progression or relapse are censored on the last assessment date. Median OS and PFS are calculated using Kaplan-Meier estimates with a 95% confidence interval.	10years
Secondary	Treatment-related mortality	Treatment-related mortality was defined as death unrelated to refractory or progressive disease occurring before first remission was achieved, or any death in complete remission	10years
Secondary	Complete remission rate	Response assessment is performed according to the criteria reported by BD Cheson et al. (Revised recommendations of the international working group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia)	10 years