NCT05991908

Brief Summary

Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15\~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (\<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P25-P50 for phase_3

Timeline
2mo left

Started Oct 2023

Typical duration for phase_3

Geographic Reach
1 country

9 active sites

Status
recruiting

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 Progress95%
Oct 2023Jun 2026

First Submitted

Initial submission to the registry

August 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 19, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

August 8, 2023

Last Update Submit

February 14, 2025

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

Keywords

conditioning regimen, melphalan, busulfan, fludarabine

Outcome Measures

Primary Outcomes (1)

  • disease-free survival

    event defined as relapse and death of any causes

    2 year

Secondary Outcomes (4)

  • overall survival

    2 year

  • incidence of relapse

    2 year

  • non relapse mortality

    day 100

  • non relapse mortality

    2 year

Study Arms (2)

Flu-Bu2-Mel140

EXPERIMENTAL

Patients receive fludarabine, busulfan and melphalan as conditioning regimen

Drug: Fludarabine, busulfan and melphalan

Flu-Bu4

ACTIVE COMPARATOR

Patients receive fludarabine and busulfan as conditioning regimen

Drug: Fludarabine and Busulfan

Interventions

Fludarabine, busulfan and melphalanDRUG

FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2

Flu-Bu2-Mel140
Fludarabine and BusulfanDRUG

FLudarabine 150mg/m2 + Busulfan 12.8mg.kg

Flu-Bu4

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission
  • myelodysplasia syndrome with bone marrow blast \>5% and remaining less than 20% at transplantation
  • patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors
  • inform consent provided

You may not qualify if:

  • AML patients with active CNS or extramedullary diseases
  • patients with active viral, bacterial or fungal infection
  • patients with hepatitis B virus \>1X103 copy/ml
  • patients with abnormal liver function, renal function, respiratory or cardiac dysfunction
  • patients with uncontrolled mental disorders
  • patients with HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Zhongshan Hospital, Xianmen University

Xiamen, Fujian, 361004, China

RECRUITING

923th Hospital PLA

Nanning, Guangxi, 530021, China

RECRUITING

First Affiliated Hospital of Nanjin Medical Unviersity

Nanjin, Jiangsu, 210029, China

RECRUITING

First Affiliatied Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai No10 Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

920th Hospital PLA

Kunming, 650000, China

RECRUITING

Shanghai No 6 Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

fludarabineBusulfanMelphalan

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Chun Wang

    Go Broad Health Center, Zhaxin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

chun Wang

CONTACT

13386259777wangchunsh@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: study group with fludarabine, busulfan and melphalan regimen versus control group with fludarabine and busulfan
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Blood & Marrow Transplantation Center, Rui Jin Hospital

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 15, 2023

Study Start

October 19, 2023

Primary Completion

October 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(9)