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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03337568
Acronym
AML_AlloHCT
Enrollment
110
Registered
2017-11-09
Start date
2017-04-01
Completion date
2021-03-30
Last updated
2019-07-08

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

Conditions

Acute Myeloid Leukemia

Keywords

AML CR, allogeneic hematopoietic cell transplantation, busulfan, fludarabine, ATG

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 (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.

Interventions

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

Sponsors

Korea Research Institute of Bioscience & Biotechnology
CollaboratorOTHER_GOV
Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
leukemia recurrencefrom HCT (day of donor cell infusion) to leukemia recurrence at 2 years after HCTreappearance of blast \>5% in bone marrow; reappearance of leukemia blast in extramedullary sites
engraftmentfrom HCT to neutrophil count over >500/uL at 30 days after HCTrecovery of absolute neutrophil count over \>500/uL
GVHD, acute and chronicfrom HCT to the occurrence of GVHD at 2 years after HCToccurrence of acute or chronic GVHD after HCT
Non-relapse mortalityfrom HCT to the occurrence of death without leukemia recurrence at 2 years after HCToccurrence of death without leukemia recurrence

Secondary

MeasureTime frameDescription
relapse free survivalfrom HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCTsurvival without leukemia recurrence/death
overall survivalfrom HCT to the last follow-up or death at 2 years after HCTsurvival regardless of leukemia recurrence

Countries

South Korea

Contacts

Primary ContactKyoo-Hyung Lee, MD
khlee2@amc.seoul.kr82-2-3010-3213
Backup ContactSeunghyun Baek, RN
bsh5932@naver.com82-2-3010-7289

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026