Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Korea Research Institute of Bioscience & Biotechnology | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic hematopoietic cell transplantation | Procedure | perform allogeneic hematopoietic cell transplantation (HCT) using conditioning regimen of busulfan, fludarabine, and antithymocyte globulin |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Not provided
Not provided
This is a single center, observational study in a patient population with non-promyelocytic AML who have achieved complete remission after induction chemotherapy. The patients will be enrolled consecutively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyoo-Hyung Lee, MD | Contact | 82-2-3010-3213 | khlee2@amc.seoul.kr | |
| Seunghyun Baek, RN | Contact | 82-2-3010-7289 | bsh5932@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Kyoo-Hyung Lee, MD | University of Ulsan, Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21715313 | Background | 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. | |
| 28552421 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
peripheral blood mononuclear cells
| from HCT to the last follow-up or death at 2 years after HCT |
| Result |
| 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 Hematopoietic Cell Transplantation from Unrelated or Haploidentical Family Donors in Patients with Acute Myeloid Leukemia in Remission. Biol Blood Marrow Transplant. 2017 Sep;23(9):1555-1566. doi: 10.1016/j.bbmt.2017.05.025. Epub 2017 May 25. |
| 36370064 | Derived | Choi Y, Choi EJ, Park HS, Lee JH, Lee JH, Lee YS, Kang YA, Jeon M, Woo JM, Kang H, Baek S, Kim SM, Bong CE, Lee KH. A uniform conditioning regimen of busulfan, fludarabine, and antithymocyte globulin for allogeneic haematopoietic cell transplantation from haploidentical family, matched sibling, or unrelated donors-A single-centre, prospective, explorative study. Br J Haematol. 2023 Mar;200(5):608-621. doi: 10.1111/bjh.18550. Epub 2022 Nov 12. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |