Treatment for elderly patients with higher-risk myelodysplastic syndromes
Official title: Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT for Elderly Patients With Higher-risk Myelodysplastic Syndromes
Run by Navy General Hospital, Beijing · NCT06471946 · Data updated 2026-11-12
This study is testing a new treatment combining two medications followed by a stem cell transplant to see if it helps older patients with higher-risk myelodysplastic syndromes live longer and have fewer complications.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 70 Years and up |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Navy General Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | September 1, 2029 |
| Study ends | September 1, 2030 |
| Registry record updated | October 1, 2024 |
| Trial ID | NCT06471946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are elderly patients diagnosed with higher-risk myelodysplastic syndromes who can meet the trial's clinical requirements.
✕Probably not a fit
Patients with active or uncontrolled infections or significant systemic disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1/2 trial aims to evaluate the safety and efficacy of a conditioning regimen combining Venetoclax and Azacytidine followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) in elderly patients diagnosed with higher-risk myelodysplastic syndromes (MDS). The study will assess overall survival, progression-free survival, and the incidence of complications such as graft-versus-host disease over a two-year period post-transplantation. The trial will include patients who meet specific clinical criteria and are willing to adhere to the study protocol.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for elderly patients with higher-risk MDS.
How similar studies have gone: While there have been studies on similar treatments, this specific combination and approach in elderly higher-risk MDS patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Navy General Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Liren Qian, PhD — Navy General Hospital, Beijing
- Study coordinator: Liren Qian, PhD
- Email: qlr2007@126.com
- Phone: +861066947192
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Bexmarilimab with Azacitidine vs Placebo with Azacitidine in Adults with Higher-Risk MDS
This phase 2b study tests whether adding bexmarilimab to azacitidine helps adults with newly diagnosed higher-risk myelodysplastic syndromes compared with azacitidine alone.
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AZD3632, alone or with other anticancer agents, for advanced blood cancers driven by HOX overexpression
This trial will test whether the oral drug AZD3632, given alone or with the antifungal posaconazole, is safe and helps control relapsed or refractory AML, ALL, or high-risk MDS that have KMT2A rearrangements, NPM1 mutations, or other genotypes causing HOX overexpression.
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Investigating REM-422 for patients with higher risk MDS or relapsed AML
This study is testing a new oral medication called REM-422 to see if it can help people with higher risk myelodysplastic syndromes or relapsed acute myeloid leukemia feel better and fight their cancer.
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Evaluating AK117 with Azacitidine for higher-risk Myelodysplastic Syndromes
This study is testing if a new treatment combining AK117 with azacitidine can help people recently diagnosed with higher-risk myelodysplastic syndromes feel better compared to standard treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.