NCT03337568

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

4 years

First QC Date

November 6, 2017

Last Update Submit

July 5, 2019

Conditions

Acute Myeloid Leukemia

Keywords

AML CRallogeneic hematopoietic cell transplantationbusulfanfludarabineATG

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • relapse free survival

    from HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCT

  • overall survival

    from HCT to the last follow-up or death at 2 years after HCT

Interventions

allogeneic hematopoietic cell transplantationPROCEDURE

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

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 21715313BACKGROUND

  • 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.

    PMID: 28552421RESULT

  • 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.

    PMID: 36370064DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cells

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Kyoo-Hyung Lee, MD

    University of Ulsan, Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyoo-Hyung Lee, MD

CONTACT

82-2-3010-3213khlee2@amc.seoul.kr

Seunghyun Baek, RN

CONTACT

82-2-3010-7289bsh5932@naver.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 9, 2017

Study Start

April 1, 2017

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)