VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS

Phase 1

Recruiting

• Conditions: Higher-risk Myelodysplastic Syndromes
• Interventions: Drug: Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT

• Registration Number: NCT06471946
• Lead Sponsor: Navy General Hospital, Beijing

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.

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.

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-18
• Study First Posted: 2024-06-24
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-28
• Study Start: 2024-10-01
• Last Update Posted: 2024-10-01
• Primary Completion: 2029-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT	Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT	Patients were treated by Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT

Primary Outcome Measures

Name	Time	Method
Overall Survival	3 year	OS was defined as time from diagnosis to death from any cause or the last follow-up

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	3 year	For patients in morphologic remission, documented relapse was considered progression.
Incidence of acute GVHD and chronic GVHD	3 year	Incidence rate of acute GVHD and chronic GVHD
Non-relapse mortality (NRM)	3 year	Non-relapse mortality (NRM) was defined as death from any cause not subsequent to relapse.
Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS)	3 year	Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS) was defined as petients without GVHD and relapse

Trial Locations

Locations (1)

Navy General Hospital; 🇨🇳 Beijing, Beijing, China