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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2030-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Higher-risk Myelodysplastic Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT

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

Group Type EXPERIMENTAL

Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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VA Conditioning Regimen Allo-HSCT

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No