Hypomemylating Agents Combination With eDC Therapy 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
Affiliated Hospital to Academy of Military Medical Sciences
40 participants
Jul 1, 2021
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to optimize the traditional treatment scheme and explore the cure scheme for the elderly by combining the existing mature treatment technology. The primary aim of this innovative immunotherapy using WT1/hTERT/Survivin-loaded DCs is to determine whether this novel DC vaccination is safe and can significantly prevent clinical relapse and increase survival of MDS patients.
Eligibility
Inclusion Criteria5
- elderly MDS patients;
- aged more than 60 years old, general condition, ECOG score less than 1;
- normal function of heart, liver and kidney, serum bilirubin ≤ 35 umol / L; serum creatinine ≤ 150 umol / L;
- patients are unsuitable or unwilling to receive hematopoietic stem cell transplantation;
- subjects sign informed consent.
Exclusion Criteria3
- serious infection was not controlled before treatment;
- contraindications for the use of dexitabine and azacytidine;
- other cases that did not meet the admission criteria.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
EDC cell therapy collection and administration process. Collection of PBMC for preparation of DC cells for patients with autologous DC cells, patient PBMC was collected 10-16 weeks before administration for the preparation and large-scale culture of DC cells. For the patients with matched DC cells, a small amount of peripheral blood was taken for HLA typing 4 weeks before administration, and then the matched DC cells were cultured on a large scale.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04999943