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

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT03337568
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-05
• Last Update Posted: 2019-07-08
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GVHD, acute and chronic	from HCT to the occurrence of GVHD at 2 years after HCT	occurrence of acute or chronic GVHD after HCT
Non-relapse mortality	from HCT to the occurrence of death without leukemia recurrence at 2 years after HCT	occurrence of death without leukemia recurrence
engraftment	from HCT to neutrophil count over >500/uL at 30 days after HCT	recovery of absolute neutrophil count over \>500/uL
leukemia recurrence	from HCT (day of donor cell infusion) to leukemia recurrence at 2 years after HCT	reappearance of blast \>5% in bone marrow; reappearance of leukemia blast in extramedullary sites

Secondary Outcome Measures

Name	Time	Method
relapse free survival	from HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCT	survival without leukemia recurrence/death
overall survival	from HCT to the last follow-up or death at 2 years after HCT	survival regardless of leukemia recurrence

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of