NCT03530085

Brief Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

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
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2018

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

May 8, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

2.8 years

First QC Date

May 8, 2018

Last Update Submit

December 18, 2020

Conditions

Acute Myeloid LeukemiaAllogeneic Hematopoietic Stem Cell TransplantationConditioningElderly

Outcome Measures

Primary Outcomes (1)

  • overall survival (OS)

    2 year

Secondary Outcomes (3)

  • disease-free survival (DFS)

    2 year

  • relapse

    2 year

  • transplant-related mortality (TRM)

    2 year

Study Arms (1)

Dec+Flu+Bu Conditioning Regimen

EXPERIMENTAL

For AML patients older than 60 years in CR, Decitabine+ Fludarabine+Busulfan conditioning regimen was used (Decitabine 20mg/m2/day on days -9 to -7；Fludarabine(Flu) 30mg/m2/day on days -6 to -3；Busulfan (BU) 3.2 mg/kg/day on days -5 to -4).

Drug: DecitabineDrug: Busulfan (BU)Drug: Fludarabine(Flu)

Interventions

DecitabineDRUG

Decitabine was administered at 20mg/m2/day on days -9 to -7.

Dec+Flu+Bu Conditioning Regimen
Busulfan (BU)DRUG

Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.

Dec+Flu+Bu Conditioning Regimen
Fludarabine(Flu)DRUG

Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.

Dec+Flu+Bu Conditioning Regimen

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AML patients older than 60 years, younger than 80 years
  • In complete remission before transplantation
  • With HLA-matched sibling donors

You may not qualify if:

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Patients with any conditions not suitable for the trial (investigators' decision)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (1)

  • Liu Q, Hu Z, Xu N, Jiang Y, Fan Z, Huang F, Lin R, Jin H, Zeng Y, He H, Zhu P, Yu G, Shi P, Sun R, Xu X, Li Z, Zhang Y, Sun J, Wang Y, Xuan L. Decitabine combined with reduced-intensity conditioning for older patients with acute myeloid leukemia in composite complete remission undergoing allogeneic hematopoietic stem cell transplantation: a multicenter, single-arm, phase 2 trial. Lancet Reg Health West Pac. 2025 Aug 12;61:101664. doi: 10.1016/j.lanwpc.2025.101664. eCollection 2025 Aug.

    PMID: 40831735DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

DecitabineBusulfan

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesButylene GlycolsGlycolsAlcoholsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Qifa Liu

    Department of Hematology,Nanfang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Xuan

CONTACT

008615521251270356135708@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 21, 2018

Study Start

June 15, 2018

Primary Completion

April 1, 2021

Study Completion

April 1, 2022

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)