NCT04713956

Brief Summary

Allo-HSCT is the most effective way to cure MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS 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
242

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2021

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

January 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

January 15, 2021

Last Update Submit

January 15, 2021

Conditions

Myelodysplastic SyndromeAllogeneic Hematopoietic Stem Cell TransplantationConditioning

Outcome Measures

Primary Outcomes (1)

  • Non-relapse mortality (NRM)

    1 year

Secondary Outcomes (3)

  • Overall survival (OS)

    1 year

  • Disease-free survival (DFS)

    1 year

  • Relapse rate

    1 year

Study Arms (2)

G-CSF+DAC+BF

EXPERIMENTAL

For patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo- HSCT, Granulocyte Colony-Stimulating Factor (G-CSF)+Decitabine+BF conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -6 to -3, Fludarabine (FLU) 30mg/m2/ day on days -7 to -3.

Drug: Granulocyte Colony-Stimulating Factor(G-CSF)Drug: Decitabine (DAC)Drug: Busulfan (BU)Drug: Fludarabine (FLU)

G-CSF+DAC+BUCY

ACTIVE COMPARATOR

For patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo- HSCT, Granulocyte Colony-Stimulating Factor (G-CSF)+Decitabine+BUCY conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -7 to -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3 to -2.

Drug: Granulocyte Colony-Stimulating Factor(G-CSF)Drug: Decitabine (DAC)Drug: Busulfan (BU)Drug: Cyclophosphamide (CY)

Interventions

Granulocyte Colony-Stimulating Factor(G-CSF)DRUG

G-CSF was administered at 5 ug/kg/day on days-17 to -10. When white blood cell is more than 20G/L, stop using G-CSF.

G-CSF+DAC+BFG-CSF+DAC+BUCY
Decitabine (DAC)DRUG

Decitabine was administered at 20mg/m2/day on days -14 to -10.

G-CSF+DAC+BFG-CSF+DAC+BUCY
Busulfan (BU)DRUG

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group, and it was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group .

G-CSF+DAC+BFG-CSF+DAC+BUCY
Cyclophosphamide (CY)DRUG

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

G-CSF+DAC+BUCY
Fludarabine (FLU)DRUG

Fludarabine was administered at 30 mg/m2/day on days -7 to -3.

G-CSF+DAC+BF

Eligibility Criteria

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

You may qualify if:

  • RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT
  • years

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

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

DecitabineBusulfanCyclophosphamidefludarabine

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesButylene GlycolsGlycolsAlcoholsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Qifa Liu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Xuan

CONTACT

+86-020-62787883356135708@qq.com

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 15, 2021

First Posted

January 19, 2021

Study Start

January 15, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2024

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

CN(1)