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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myelodysplastic Syndromes
- Sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- OS
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
Objective Myelodysplastic syndrome (Myelodysplasticsyndromes,MDS) is a highly age-related malignant clonal disease of the hematological system, which is characterized by pancytopenia and transformation to leukemia. In China, the median age of onset of MDS is 70 years old, and the incidence increases with age. It is the most common malignant tumor in the elderly, which seriously threatens the health and survival of the elderly. The 3-year survival rate of traditional combination chemotherapy or demethylation therapy is less than 20%.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 criteria:
- •serious infection was not controlled before treatment;
- •contraindications for the use of dexitabine and azacytidine;
- •other cases that did not meet the admission criteria.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
OS
Time Frame: at study completion, an average of 3 years
Overall survival
Secondary Outcomes
- RFS(at study completion, an average of 3 years)
- RR(at study completion, an average of 3 years)
- the Incidence of Treatment Adverse Events(at study completion, an average of 3 years)