Higher-risk Myelodysplastic SyndromesPhase 1/2NCT06471946
VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS
A Phase 1/2 study testing Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT in people with Higher-risk Myelodysplastic Syndromes, run by Navy General Hospital, Beijing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Higher-risk Myelodysplastic Syndromes
- What is being tested?
- Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Sep 2030
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Navy General Hospital
Beijing, Beijing Municipality, 100048
Liren Qian, M.D., +861066957676, qlr2007@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Higher-risk Myelodysplastic Syndromes
- Being tested
- Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCTDrug
Also called VA 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
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT | Experimental | Patients were treated by Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT Receives: Drug: Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
OS was defined as time from diagnosis to death from any cause or the last follow-up
Measured: 3 year
Secondary outcomes (4)
Progression Free Survival (PFS)
For patients in morphologic remission, documented relapse was considered progression.
Measured: 3 year
Incidence of acute GVHD and chronic GVHD
Incidence rate of acute GVHD and chronic GVHD
Measured: 3 year
Non-relapse mortality (NRM)
Non-relapse mortality (NRM) was defined as death from any cause not subsequent to relapse.
Measured: 3 year
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
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Higher-risk Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liren Qian, Navy General Hospital, Beijing
- Investigators
- Liren Qian, PhD, Principal investigator, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471946
- Sponsor's protocol ID
- VAHCT2024
- Status last verified
- Sep 2024
- First submitted
- 17 Jun 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No