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

Acute Myeloid Leukemia Clinical Trial

— AML_AlloHCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03337568
• Other study ID #: 2017-0204
• Status: Recruiting
• Start date: April 1, 2017
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2019
• Source: Asan Medical Center
• Contact: Kyoo-Hyung Lee, MD
• Phone: 82-2-3010-3213
• Email: khlee2[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Korea Research Institute of Bioscience & Biotechnology

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Lee KH, Lee JH, Lee JH, Kim DY, Park HS, Choi EJ, Ko SH, Seol M, Lee YS, Kang YA, Jeon M, Baek S, Kang YL, Kim SH, Yun SC, Kim H, Jo JC, Choi Y, Joo YD, Lim SN. Reduced-Intensity Conditioning with Busulfan, Fludarabine, and Antithymocyte Globulin for Hema — View Citation

Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	engraftment	recovery of absolute neutrophil count over >500/uL	from HCT to neutrophil count over >500/uL at 30 days after HCT
Primary	GVHD, acute and chronic	occurrence of acute or chronic GVHD after HCT	from HCT to the occurrence of GVHD at 2 years after HCT
Primary	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	relapse free survival	survival without leukemia recurrence/death	from HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCT
Secondary	overall survival	survival regardless of leukemia recurrence	from HCT to the last follow-up or death at 2 years after HCT