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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Procedure: allogeneic hematopoietic cell transplantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: allogeneic hematopoietic cell transplantation|perform allogeneic hematopoietic cell transplantation (HCT) using conditioning regimen of busulfan, fludarabine, and antithymocyte globulin|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse free survival | survival without leukemia recurrence/death | from HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCT | 
| overall survival | survival regardless of leukemia recurrence | from HCT to the last follow-up or death at 2 years after HCT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML CR, allogeneic hematopoietic cell transplantation, busulfan, fludarabine, ATG