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

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ClinicalTrials.gov Identifier: NCT03337568
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Korea Research Institute of Bioscience & Biotechnology
Information provided by (Responsible Party):
Kyoo-Hyung Lee, Asan Medical Center

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.


Condition or disease Intervention/treatment
Acute Myeloid Leukemia Procedure: allogeneic hematopoietic cell transplantation

Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021



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


Primary Outcome Measures :
  1. 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

  2. engraftment [ Time Frame: from HCT to neutrophil count over >500/uL at 30 days after HCT ]
    recovery of absolute neutrophil count over >500/uL

  3. 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

  4. 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


Secondary Outcome Measures :
  1. relapse free survival [ Time Frame: from HCT to last the follow-up, leukemia recurrence, or death at 2 years after HCT ]
    survival without leukemia recurrence/death

  2. overall survival [ Time Frame: from HCT to the last follow-up or death at 2 years after HCT ]
    survival regardless of leukemia recurrence


Biospecimen Retention:   Samples With DNA
peripheral blood mononuclear cells


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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337568


Contacts
Contact: Kyoo-Hyung Lee, MD 82-2-3010-3213 khlee2@amc.seoul.kr
Contact: Seunghyun Baek, RN 82-2-3010-7289 bsh5932@naver.com

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyoo-Hyung Lee, MD    82-2-3010-3213    khlee2@amc.seoul.kr   
Contact: Inpyo Choi, PhD    82-42-860-4223    ipchoi@kribb.re.kr   
Sponsors and Collaborators
Asan Medical Center
Korea Research Institute of Bioscience & Biotechnology
Investigators
Principal Investigator: Kyoo-Hyung Lee, MD University of Ulsan, Asan Medical Center

Publications of Results:
Other Publications:
Responsible Party: Kyoo-Hyung Lee, MD, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03337568     History of Changes
Other Study ID Numbers: 2017-0204
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kyoo-Hyung Lee, Asan Medical Center:
AML CR
allogeneic hematopoietic cell transplantation
busulfan
fludarabine
ATG

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Fludarabine
Fludarabine phosphate
Busulfan
Antilymphocyte Serum
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists