Hypomemylating Agents Combination With eDC Therapy for Elderly Patients With Myelodysplastic Syndrome
NCT ID: NCT04999943
Last Updated: 2021-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2021-07-01
2026-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Hypomemylating agent monotherapy
Azacitidine 100mg/ times. d × for 10 days (28 days for one cycle) or Decitabine 25mg/ times. d × 5 days ( 28 days is one cycle)
DC vaccine
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.
Combined cellular immunotherapy（eDC）with Hypomemylating agent therapy
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
DC vaccine
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.
Interventions
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DC vaccine
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.
Eligibility Criteria
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Inclusion Criteria
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
2. contraindications for the use of dexitabine and azacytidine;
3. other cases that did not meet the admission criteria.
60 Years
ALL
No
Sponsors
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Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Liangding Hu, Prof.
Role: STUDY_CHAIR
the Fifth Medical Center the PLA General Hospital
Locations
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Department of hematology
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2107-Hem-1-eDC
Identifier Type: -
Identifier Source: org_study_id
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