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

Navy General Hospital, Beijing

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Higher-risk Myelodysplastic Syndromes

Treatments

Drug: Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT

Study type

Interventional

Funder types

Other

Identifiers

NCT06471946

VAHCT2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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.