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

September 28, 2024 updated by: Liren Qian, Navy General Hospital, Beijing

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100048
        • Recruiting
        • Navy General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
Patients were treated by Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
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

Other Names:
  • VA Conditioning Regimen Allo-HSCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 year
OS was defined as time from diagnosis to death from any cause or the last follow-up
3 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Investigators

  • Principal Investigator: Liren Qian, PhD, Navy General Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 28, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAHCT2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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