Aza-Ven Followed by Reduced Toxicity Conditioning Regimen (MBF) as Salvage Therapy for Refractory AML.
Azacytidine-venetoclax Combination as Leukemia Debulking Treatment Followed by Reduced Toxicity Conditioning Regimen (Melphalan Busulfan and Fludarabine, MBF) as Salvage Therapy for Refractory Acute Myeloid Leukemia (AML).
1 other identifier
interventional
23
1 country
3
Brief Summary
In this phase clinical trail, we evaluate the efficacy and feasibility of azacytidine and venetoclax as leukemia debulking treatment followed by reduced intensity conditioning regimen consisting of Fludarabine + Busulfan + Melphalan as salvage treatment in patients with refractory AML .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2021
Typical duration for phase_2
3 active sites
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
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 22, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJune 1, 2021
May 1, 2021
3 years
May 22, 2021
May 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
relapse-free survival
event defined as relapse or death of any causes
12 months
Secondary Outcomes (4)
overall survival
12 months
non-relapse mortality
12 months
relapse
12 months
GVHD and relapse free survival (GRFS)
12 months
Study Arms (1)
aza-ven +MBF
EXPERIMENTALtreatment with aza-ven debulking therapy followed by allo-HSCT with MBF conditioning
Interventions
aaa-ven treatment followed by allo-HCTS with reduced toxicity conditioning (RTC) of Fludarabine, Busulifan and Melphalan
Eligibility Criteria
You may qualify if:
- refractory AML (no remission after 2 induction therapy, relapsed AML within 6 months of first complete remission (CR), relapse AML no CR after reinduction therapy), multiple relapse and refractory relapse AML
- patients with HLA matched related or unrelated donor (9\~10/10) or haplo-identical related donor
You may not qualify if:
- Patients with poor liver function (enzyme \>2N or bilirubin \>2N)
- poor renal function (Scr \>1.5N)
- poor cardiac function （EF\<45%）
- inform consent not provided
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, 200025, China
Department of Hematology, Shanghai No6 Hospital
Shanghai, China
Shanghai ZhaXin Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiong HU
Shanghai Rui Jin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head BMT program, Rui Jin Hospital
Study Record Dates
First Submitted
May 22, 2021
First Posted
May 27, 2021
Study Start
January 1, 2021
Primary Completion
January 1, 2024
Study Completion
June 1, 2024
Last Updated
June 1, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share