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NCT Number: NCT06471946

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

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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Key information

Conditions

Higher-risk Myelodysplastic Syndromes

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

Location status: Recruiting

Location contact

Liren Qian, M.D.

CONTACT

[email protected]

+861066957676

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT

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

Other names: VA Conditioning Regimen Allo-HSCT

Primary outcomes

  1. Overall Survival

    Time frame: 3 year

    OS was defined as time from diagnosis to death from any cause or the last follow-up

Secondary outcomes

  1. Progression Free Survival (PFS)

    Time frame: 3 year

    For patients in morphologic remission, documented relapse was considered progression.

  2. Incidence of acute GVHD and chronic GVHD

    Time frame: 3 year

    Incidence rate of acute GVHD and chronic GVHD

  3. Non-relapse mortality (NRM)

    Time frame: 3 year

    Non-relapse mortality (NRM) was defined as death from any cause not subsequent to relapse.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Liren Qian, PhD

CONTACT

[email protected]

+861066947192

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Jun 24, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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