To hear about similar clinical trials, please enter your email below
Trial Title:
VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS
NCT ID:
NCT06471946
Condition:
Higher-risk Myelodysplastic Syndromes
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
Description:
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
Arm group label:
Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
Other name:
VA Conditioning Regimen Allo-HSCT
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.
Detailed description:
The investigators will evaluate 2 year overall survival(OS) after transplantation in
patients with higher-risk MDS. Progression free survival (PFS), incidence of acute GVHD,
non-relapse mortality (NRM), graft-versus-host disease (GVHD)-free relapse-free
survival(GRFS), and incidence of chronic GVHD at 1 and 2 years after transplantation will
be counted.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Navy General Hospital
Address:
City:
Beijing
Zip:
100048
Country:
China
Status:
Recruiting
Contact:
Last name:
Liren Qian, M.D.
Phone:
+861066957676
Email:
qlr2007@126.com
Start date:
October 1, 2024
Completion date:
September 1, 2030
Lead sponsor:
Agency:
Navy General Hospital, Beijing
Agency class:
Other
Source:
Navy General Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06471946
