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Recruiting NCT06471946

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

Phase I / Phase II Interventional Higher-risk Myelodysplastic Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT.
Who it may be relevant to
Registry conditions: Higher-risk Myelodysplastic Syndromes. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT for Elderly Patients With Higher-risk Myelodysplastic Syndromes

Overview

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.

Interventions

  • Drug Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
    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

Primary outcome measures

  • Overall Survival [Time frame: 3 year]
Secondary outcome measures (4)
  • Progression Free Survival (PFS) [Time frame: 3 year]
  • Incidence of acute GVHD and chronic GVHD [Time frame: 3 year]
  • Non-relapse mortality (NRM) [Time frame: 3 year]
  • Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS) [Time frame: 3 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Navy General Hospital — Beijing

Identifiers

NCT: NCT06471946 · VAHCT2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗