Health TrialsbyHealthPanel

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

ConditionHigher-risk Myelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age70+
SponsorNavy General Hospital, Beijing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

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

Time frame
3 year

Secondary outcomes

1

Progression Free Survival (PFS)

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

Time frame
3 year
2

Incidence of acute GVHD and chronic GVHD

Incidence rate of acute GVHD and chronic GVHD

Time frame
3 year
3

Non-relapse mortality (NRM)

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

Time frame
3 year
4

Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS)

Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS) was defined as petients without GVHD and relapse

Time frame
3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Navy General Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov
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