NCT03337568

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

Allogeneic HCT From Donor-sources of Matched-sibling, Matched-unrelated, or Haploidentical-family Donors Using Uniform Conditioning Regimen of Busulfan, Fludarabine, and Antithymocyte Globulin for AML in Remission - an Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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 (HCT) using uniform conditioning regimen including busulfan, fludarabine, and antithymocyte globulin (ATG) in patients with acute myeloid leukemia (AML) in the first complete remission (CR). The donors for allogeneic HCT include HLA-matched siblings, matched unrelated donors, and haploidentical family donors. Therefore, the endpoints of the study are engraftment, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, leukemia recurrence, non-relapse mortality, and relapse-free (RFS) and overall survival (OS) of patients.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
PROCEDURE	allogeneic hematopoietic cell transplantation	perform allogeneic hematopoietic cell transplantation (HCT) using conditioning regimen of busulfan, fludarabine, and antithymocyte globulin

Timeline

• Start date: 2017-04-01
• Primary completion: 2021-03-30
• Completion: 2021-03-30
• First posted: 2017-11-09
• Last updated: 2019-07-08

Locations

1 site across 1 country: South Korea