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Allogeneic HCT Using Conditioning Regimen of BuFluATG for AML CR1

NCT07155382 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2025-09-04

No results posted yet for this study

Summary

1. Study Objectives

* 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.
* 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.
2. Patient Eligibility

* 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.
3. Treatment Plan

Patients in the study will receive conditioning therapy with busulfan, fludarabine, and antithymocyte globulin. If patients are 54 years old or younger, the patients will receive three days' busulfan administration. If patients are older than 54 years or have co-morbidity, the patients will receive two days' busulfan administration. Graft is non-T cell depleted mobilized peripheral blood hematopoietic cells. GVHD prophylaxis will be given with cyclosporine 1.5 mg/kg iv infusion q12 hrs beginning day -1; methotrexate 15 mg/m2 iv push one day after HCT, then 10 mg/m2 3 days and 6 days after HCT
4. Treatment Evaluation

Regimen related toxicities will be graded by NCI, Common Toxicity Criteria, v 4.0. The status of mixed chimerism will be evaluated by PCR analysis of short tandem repeats (STRs) of one of nine polymorphic introns or amelogenin. The chimerism status will be analyzed from mononuclear cells on 1, 3, and 6 months after HCT. Immune recovery of the patients after stem cell transplantation will be monitored by lymphocyte subset count and measurement of Ig G, Ig M, Ig A levels and Ig G subset (G1, G2, G3) on 1, 3, 6, and 12 months. In the study, at least 200 evaluable cases of HCT will be performed.

Conditions

  • Acute Myeloid Leukemia (AML)

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2024-05-27
Completion
2024-08-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07155382 on ClinicalTrials.gov