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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02344953

Enrollment

1000

Registered

2015-01-26

Start date

2011-01-31

Completion date

2021-01-31

Last updated

2019-03-18

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

Conditions

Acute Leukemia

Brief 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

South Korea

Contacts

Primary ContactJUNE-WON CHEONG, MD

JWCHONG70@yuhs.ac82-2-2228-1970

Outcome results