Combining immunotherapy with hypomethylating agents for elderly patients with myelodysplastic syndrome
A Randomized, Open-label, Clinical Trial to Compare the Safety and Efficacy of Hypomemylating Agents Monotherapy and Combination With eDC Therapy for Elderly Patients With Myelodysplastic Syndrome
This study is testing a new treatment that combines a special vaccine with existing medications to see if it helps older patients with myelodysplastic syndrome live longer and avoid relapses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Affiliated Hospital to Academy of Military Medical Sciences Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT04999943 on ClinicalTrials.gov |
What this trial studies
This study aims to improve treatment outcomes for elderly patients with myelodysplastic syndrome (MDS) by combining hypomethylating agents with dendritic cell (DC) therapy. The primary goal is to assess the safety and efficacy of a novel DC vaccination loaded with specific antigens to prevent clinical relapse and enhance survival rates. Given the high incidence of MDS in older adults, this innovative approach seeks to optimize existing treatment strategies for this vulnerable population. The study will involve elderly patients who are not candidates for hematopoietic stem cell transplantation.
Who should consider this trial
Good fit: Ideal candidates are elderly patients over 60 years old with myelodysplastic syndrome who are not suitable for hematopoietic stem cell transplantation.
Not a fit: Patients with uncontrolled serious infections or contraindications for the use of specific medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for elderly patients suffering from myelodysplastic syndrome.
How similar studies have performed: Other studies have shown promise in using immunotherapy for MDS, but this specific combination approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. elderly MDS patients; 2. aged more than 60 years old, general condition, ECOG score less than 1; 3. normal function of heart, liver and kidney, serum bilirubin ≤ 35 umol / L; serum creatinine ≤ 150 umol / L; 4. patients are unsuitable or unwilling to receive hematopoietic stem cell transplantation; 5. subjects sign informed consent. Exclusion criteria: 1. serious infection was not controlled before treatment; 2. contraindications for the use of dexitabine and azacytidine; 3. other cases that did not meet the admission criteria.
Where this trial is running
Beijing
- Department of hematology — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yao Sun, M.D., Ph. D.
- Email: suny320@126.com
- Phone: 010-66947402
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.