VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS
Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT for Elderly Patients With Higher-risk Myelodysplastic Syndromes
1 other identifier
interventional
54
1 country
1
Brief Summary
The goal of this phase 1/2 trial is to test the safety and efficacy of Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT in treating patients with higher-risk MDS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2024
Longer than P75 for phase_1
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
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
June 24, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
October 1, 2024
September 1, 2024
4.9 years
June 17, 2024
September 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
OS was defined as time from diagnosis to death from any cause or the last follow-up
3 year
Secondary Outcomes (4)
Progression Free Survival (PFS)
3 year
Incidence of acute GVHD and chronic GVHD
3 year
Non-relapse mortality (NRM)
3 year
Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS)
3 year
Study Arms (1)
Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
EXPERIMENTALPatients were treated by Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
Interventions
Patients were treated by VA Conditioning Regimen Allo-HSCT: Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-14; Azacytidine 75 mg/m2 subcutaneous injection qd d1-7, donor stem cells infused from d9
Eligibility Criteria
You may qualify if:
- The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
- The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
- The patient should be diagnosed with higher risk MDS according to the standard criteria of the World Health Organization (WHO).
You may not qualify if:
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Navy General Hospital
Beijing, Beijing Municipality, 100048, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Liren Qian, PhD
Navy General Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director
Study Record Dates
First Submitted
June 17, 2024
First Posted
June 24, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
September 1, 2030
Last Updated
October 1, 2024
Record last verified: 2024-09