Status:

UNKNOWN

Allogeneic HCT Using Uniform Conditioning Regimen Regardless of Donors (MS, MU, or HF) for AML in Remission

Lead Sponsor:

Asan Medical Center

Collaborating Sponsors:

Korea Research Institute of Bioscience & Biotechnology

Conditions:

Acute Myeloid Leukemia

Eligibility:

All Genders

16-75 years

Brief Summary

The purpose of this study is to evaluate the effect of various clinical variables including HLA-disparity and NK cell-related variables, upon outcomes of allogeneic hematopoietic cell transplantation ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patients with non-promyelocytic AML (intermediate-risk or high-risk diseases by NCCN guideline 2016) in the first CR
  • Patients should be 16 years of age or more and 75 years of age or less
  • The performance status of the patients should be 70 or over by Karnofsky performance scale
  • Patients should have adequate hepatic function (bilirubin less than 2.0 mg/dl, AST less than three times the upper normal limit)
  • Patients should have adequate renal function (creatinine less than 2.0 mg/dl)
  • Patients should have adequate cardiac function (ejection fraction \> 40% on MUGA scan)
  • Patients and stem cell donors must sign informed consent
  • For hematopoietic cell donor, if a patient has an HLA-matched sibling (65 years or younger), that sibling will be a cell donor. If a patient does not have an HLA-matched sibling but an HLA-A, B, C, DRB1 7-8/8 matched unrelated donor, the unrelated donor will be a cell donor. If a patient has neither HLA-matched sibling nor unrelated donor, an HLA-haploidentical familial donor will be a cell donor.

Exclusion

    Key Trial Info

    Start Date :

    April 1 2017

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 30 2021

    Estimated Enrollment :

    110 Patients enrolled

    Trial Details

    Trial ID

    NCT03337568

    Start Date

    April 1 2017

    End Date

    March 30 2021

    Last Update

    July 8 2019

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Asan Medical Center

    Seoul, South Korea

    Allogeneic HCT Using Uniform Conditioning Regimen Regardless of Donors (MS, MU, or HF) for AML in Remission | DecenTrialz