NCT02671708

Brief Summary

Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2019

Enrollment Period

3.2 years

First QC Date

January 30, 2016

Last Update Submit

March 2, 2020

Conditions

Autologous Hematopoietic Stem Cell TransplantationAcute Myeloid LeukemiaConditioning

Outcome Measures

Primary Outcomes (1)

  • leukemia relapse rate

    2 year

Secondary Outcomes (3)

  • overall survival (OS)

    2 year

  • disease-free survival (DFS)

    2 year

  • transplant-related mortality (TRM)

    2 year

Study Arms (2)

IDA+BUCY

EXPERIMENTAL

For intermediate-risk AML undergoing auto-HSCT，IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10；BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.

Drug: Idarubicin（IDA）Drug: Busulfan (BU)Drug: Cyclophosphamide (CY)

BUCY

ACTIVE COMPARATOR

For intermediate-risk AML undergoing auto-HSCT，BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.

Drug: Busulfan (BU)Drug: Cyclophosphamide (CY)

Interventions

Idarubicin（IDA）DRUG

Idarubicin was administered at 15mg/m2/day on days -12 and -10.

IDA+BUCY
Busulfan (BU)DRUG

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

BUCYIDA+BUCY
Cyclophosphamide (CY)DRUG

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

BUCYIDA+BUCY

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Intermediate-risk AML
  • Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens
  • With negative MRD before mobilization and collect of peripheral blood stem cells
  • Without HLA-matched donors (related and unrelated)
  • Refusal of haploidentical hematopoietic stem cell transplantation

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

Location

Related Publications (1)

  • Liu H, Huang F, Zhang Y, Wu M, Xu N, Fan Z, Sun Z, Li X, Lin D, Xiong Y, Liu X, Lin R, Shi P, Xu J, Wang Z, Li X, Sun J, Liu Q, Xuan L. Idarubicin plus BuCy versus BuCy conditioning regimens for intermediate-risk acute myeloid leukemia in first complete remission undergoing auto-HSCT: An open-label, multicenter, randomized phase 3 trial. Am J Hematol. 2023 Mar;98(3):408-412. doi: 10.1002/ajh.26800. Epub 2023 Jan 1.

    PMID: 36588387DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

BusulfanCyclophosphamide

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Qifa Liu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 30, 2016

First Posted

February 2, 2016

Study Start

January 1, 2016

Primary Completion

February 28, 2019

Study Completion

February 28, 2020

Last Updated

March 3, 2020

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

Locations

CN(1)