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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04999943
Other study ID # 2107-Hem-1-eDC
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 1, 2021
Est. completion date July 1, 2026

Study information

Verified date August 2021
Source Affiliated Hospital to Academy of Military Medical Sciences
Contact Yao Sun, M.D., Ph. D.
Phone 010-66947402
Email suny320@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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%.


Recruitment information / eligibility

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.

Study Design


Intervention

Biological:
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.

Locations

Country Name City State
China Department of hematology Beijing

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

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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