Decitabine+BUCY vs BUCY Conditioning Regimen for MLL+ Acute Leukemia Undergoing Allo-HSCT
Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
1 other identifier
interventional
122
1 country
1
Brief Summary
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. 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 MLL+ acute leukemia 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 Jul 2018
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
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 13, 2018
CompletedFirst Posted
Study publicly available on registry
July 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJuly 24, 2018
July 1, 2018
2.9 years
July 13, 2018
July 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Decitabine + BUCY
EXPERIMENTALFor MLL+ acute leukemia 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 MLL+ acute leukemia 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:
- MLL+ acute leukemia 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
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- Guangzhou First People's Hospitalcollaborator
- Peking University People's Hospitalcollaborator
- Zhujiang Hospitalcollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
Study Sites (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu
Nanfang Hospital, Southern Medical University
Central Study Contacts
Qifa Liu
CONTACT
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 13, 2018
First Posted
July 24, 2018
Study Start
July 1, 2018
Primary Completion
June 1, 2021
Study Completion
June 1, 2022
Last Updated
July 24, 2018
Record last verified: 2018-07