ClinicalTrials.gg
Status unknownNCT02344953Updated Mar 18, 2019

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)

An observational study in Acute Leukemia, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-03-18.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
16 Years and older
Sex
All
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Study 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

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Conditions studied

  • Acute Leukemia
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Sampling is performed in patients diagnosed with acute leukemia who underwent allo-HSCT in Severance Hospital.

Every eligible patients in peroid of study are enrolled. Patients must have the ability and willingness to sign a written informed consent document. Planned number of patients is 1000 considering annual incidence rate.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10years

Secondary outcomes

  1. 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.

    Time frame: 10years

  2. 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

    Time frame: 10years

  3. 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)

    Time frame: 10 years

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Study locations

1 of 1 sites recruiting
  • Yonsei University College of Medicine
    Seoul, 120-752, South Korea
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2011, a primary completion of Dec 2020 and a completion of Jan 2021. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2014
First posted
Jan 26, 2015
Start
Jan 2011
Primary completionEst.
Dec 2020
CompletionEst.
Jan 2021
Last update
Mar 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02344953
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jan 26, 2015
Start date
Jan 2011
Primary completion
Dec 2020 (estimated)
Completion
Jan 2021 (estimated)
Last update
Mar 18, 2019

Study contacts

JUNE-WON CHEONG, MD
Contact
JWCHONG70@yuhs.ac
82-2-2228-1970

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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