Myelodysplastic Syndromes Clinical Trial
— eDC-MDSOfficial title:
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
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 1, 2026 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of hematology | Beijing |
Lead Sponsor | Collaborator |
---|---|
Affiliated Hospital to Academy of Military Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | OS | Overall survival | at study completion, an average of 3 years | |
Secondary | the Incidence of Treatment Adverse Events | The primary objective of this single-arm phase I clinical study is to determine the Incidence of Treatment Adverse Events in elder MDS or MDS/AML patients. | at study completion, an average of 3 years | |
Secondary | RR | Relapse rate | at study completion, an average of 3 years | |
Secondary | RFS | Relapse-free survival | at study completion, an average of 3 years |
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