Treatment for elderly patients with higher-risk myelodysplastic syndromes
Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT for Elderly Patients With Higher-risk Myelodysplastic Syndromes
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 |
| Enrollment | 54 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Navy General Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06471946 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients diagnosed with higher-risk myelodysplastic syndromes who can meet the trial's clinical requirements.
Not a fit: Patients with active or uncontrolled infections or significant systemic disease may not benefit from this study.
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 performed: While there have been studies on similar treatments, this specific combination and approach in elderly higher-risk MDS patients is relatively novel.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.