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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypomemylating agent monotherapy | Active Comparator | Azacitidine 100mg/ times. d × for 10 days (28 days for one cycle) or Decitabine 25mg/ times. d × 5 days ( 28 days is one cycle) |
|
| Combined cellular immunotherapy(eDC)with Hypomemylating agent therapy | Experimental | Azacitidine 100mg/ times. d × for 10 days (28 days for one cycle) or Decitabine 25mg/ times. d × 5 days ( 28 days is one cycle) with Dendritic Cell (DC) Vaccination Expressing WT1/hTERT/Survivin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | at study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| RR |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yao Sun, M.D., Ph. D. | Contact | 010-66947402 | suny320@126.com | |
| Yuxin Wang, M.D. | Contact | 010-66947109 | wyx15147159987@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liangding Hu, Prof. | the Fifth Medical Center the PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of hematology | Recruiting | Beijing | 100071 | China |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000706173 | lentiviral minigene vaccine of COVID-19 coronavirus |
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|
Relapse rate
| at study completion, an average of 3 years |
| RFS | Relapse-free survival | at study completion, an average of 3 years |