Acute Myeloid LeukemiaAML_AlloHCTNCT03337568
Allogeneic HCT Using Uniform Conditioning Regimen Regardless of Donors (MS, MU, or HF) for AML in Remission
An observational study of Acute Myeloid Leukemia, run by Asan Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- allogeneic hematopoietic cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2017to 30 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Kyoo-Hyung Lee, MD, 82-2-3010-3213, khlee2@amc.seoul.kr
Inpyo Choi, PhD, 82-42-860-4223, ipchoi@kribb.re.kr
About this study
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
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- allogeneic hematopoietic cell transplantation
- Keywords
- AML CR, allogeneic hematopoietic cell transplantation, busulfan, fludarabine, ATG
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic hematopoietic cell transplantationProcedure or surgery
perform allogeneic hematopoietic cell transplantation (HCT) using conditioning regimen of busulfan, fludarabine, and antithymocyte globulin
What is being measured
The primary outcome is the main question the study is designed to answer.
leukemia recurrence
reappearance of blast >5% in bone marrow; reappearance of leukemia blast in extramedullary sites
Measured: from HCT (day of donor cell infusion) to leukemia recurrence at 2 years after HCT
engraftment
recovery of absolute neutrophil count over >500/uL
Measured: 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
Measured: from HCT to the occurrence of GVHD at 2 years after HCT
Non-relapse mortality
occurrence of death without leukemia recurrence
Measured: from HCT to the occurrence of death without leukemia recurrence at 2 years after HCT
Secondary outcomes (2)
relapse free survival
survival without leukemia recurrence/death
Measured: from HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCT
overall survival
survival regardless of leukemia recurrence
Measured: from HCT to the last follow-up or death at 2 years after HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Apr 2017
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Research Institute of Bioscience & Biotechnology
- Responsible party
- Principal investigator, Kyoo-Hyung Lee, Asan Medical Center
- Investigators
- Kyoo-Hyung Lee, MD, Principal investigator, University of Ulsan, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337568
- Sponsor's protocol ID
- 2017-0204
- Acronym
- AML_AlloHCT
- Status last verified
- Jul 2019
- First submitted
- 6 Nov 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21715313Lee 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.
PubMed 28552421Choi 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.
PubMed 36370064
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03337568
- Acronym / sponsor ID
- AML_AlloHCT / 2017-0204
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML CR, allogeneic hematopoietic cell transplantation, busulfan, fludarabine, ATG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea Research Institute of Bioscience & Biotechnology
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic hematopoietic cell transplantationperform allogeneic hematopoietic cell transplantation (HCT) using conditioning regimen of busulfan, fludarabine, and antithymocyte globulin | Procedure or surgery | – |
Primary outcome
leukemia recurrence
Time frame: 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
engraftment
Time frame: from HCT to neutrophil count over >500/uL at 30 days after HCT
recovery of absolute neutrophil count over >500/uL
GVHD, acute and chronic
Time frame: from HCT to the occurrence of GVHD at 2 years after HCT
occurrence of acute or chronic GVHD after HCT
Non-relapse mortality
Time frame: from HCT to the occurrence of death without leukemia recurrence at 2 years after HCT
occurrence of death without leukemia recurrence
2 secondary outcomes
relapse free survival
Time frame: from HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCT
overall survival
Time frame: from HCT to the last follow-up or death at 2 years after HCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Background: PubMed 21715313Lee 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.
- Results publication: PubMed 28552421Lee 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.
- Derived from this study: PubMed 36370064Choi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyoo-Hyung Lee, MD principal investigator
University of Ulsan, Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyoo-Hyung Lee, MD (82-2-3010-3213, khlee2@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leukemia recurrence (time frame: from HCT (day of donor cell infusion) to leukemia recurrence at 2 years after HCT). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03337568, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.