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

• Conditions: Acute Leukemia

• Registration Number: NCT02344966
• Lead Sponsor: Yonsei University

Brief Summary

The objective of this study is to evaluate the prognostic factors of acute leukemia patients 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 diagnosis process, treatment and/or thereafter

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2014-12-30
• Study First Submitted QC: 2015-01-18
• Study First Posted: 2015-01-26
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Patients diagnosed with acute leukemia in Severance Hospital.
• Both genders of 16 Years and older
• sign a written informed consent document

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	10years	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	10years	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.
Treatment-related mortality	10years	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
Complete remission rate	10 years	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)

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of