NCT05453552

Brief Summary

Allo-HSCT is the most effective way to cure high-risk MDS patients. At present, the best conditioning regimen for high-risk MDS patients 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 high-risk MDS patients 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 Jul 2022

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

July 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 21, 2023

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

July 5, 2022

Last Update Submit

March 20, 2023

Conditions

Myelodysplastic SyndromeAllogeneic Hematopoietic Stem Cell TransplantationConditioning

Outcome Measures

Primary Outcomes (1)

  • Non-relapse mortality (NRM)

    1 year

Secondary Outcomes (4)

  • Overall survival (OS)

    1 year

  • Disease-free survival (DFS)

    1 year

  • Cumulative incidence of relapse

    1 year

  • Adverse effects

    within 100 days post-transplantation

Study Arms (2)

G-CSF+DAC+BF

EXPERIMENTAL

For patients with high-risk 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: Fludarabine (FLU)Drug: Busulfan (BU)

G-CSF+DAC+BUCY

ACTIVE COMPARATOR

For patients with high-risk 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, -2.

Drug: Granulocyte Colony-Stimulating Factor(G-CSF)Drug: Decitabine (DAC)Drug: BusulfanDrug: 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
BusulfanDRUG

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group.

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

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

G-CSF+DAC+BF
Cyclophosphamide (CY)DRUG

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

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

Busulfan was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group.

G-CSF+DAC+BF

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Had a diagnosis of RAEB-1 or RAEB-2 with IPSS-R \>3
  • Age 18 to 65 years old
  • ECOG performance status of 0-2
  • HCT-CI of 0-2
  • Were willing to undergo allo-HSCT

You may not qualify if:

  • Therapy-related MDS
  • Previous allo-HSCT
  • Uncontrolled infections
  • Liver or renal dysfunction
  • Severe concomitant conditions not suitable for the trial

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

DecitabineBusulfanfludarabineCyclophosphamide

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

July 5, 2022

First Posted

July 12, 2022

Study Start

July 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

March 21, 2023

Record last verified: 2022-07

Locations

CN(1)