Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT
Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Myeloid Tumors Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
1 other identifier
interventional
196
1 country
1
Brief Summary
Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in myeloid tumors undergoing allo-HSCT are evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 19, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedSeptember 23, 2019
September 1, 2019
2.9 years
September 19, 2019
September 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
relapse rate
1 year
Secondary Outcomes (3)
overall survival (OS)
1 year
disease-free survival (DFS)
1 year
transplant-related mortality (TRM)
1 year
Study Arms (2)
Decitabine + BUCY
EXPERIMENTALFor myeloid tumors undergoing allo-HSCT, Decitabine+BUCY conditioning regimen was Decitabine 20mg/m2/day on days -14 and -10, Busulfan (BU) 3.2 mg/kg/day on days -7 and -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2.
BUCY
ACTIVE COMPARATORFor myeloid tumors undergoing allo-HSCT, BUCY conditioning regimen was Busulfan (BU) 3.2 mg/kg/day on days -7 and -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2.
Interventions
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Eligibility Criteria
You may qualify if:
- Myeloid tumors 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
- Nanfang Hospital, Southern Medical Universitylead
- Peking University People's Hospitalcollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Zhujiang Hospitalcollaborator
Study Sites (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu
Nanfang Hospital, Southern Medical University
Central Study Contacts
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
September 19, 2019
First Posted
September 23, 2019
Study Start
September 1, 2019
Primary Completion
August 1, 2022
Study Completion
August 1, 2023
Last Updated
September 23, 2019
Record last verified: 2019-09