Hypomemylating Agents Combination With eDC Therapy for Elderly Patients With Myelodysplastic Syndrome

Myelodysplastic Syndromes Clinical Trial

— eDC-MDS  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04999943
• Other study ID #: 2107-Hem-1-eDC
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Hypomethylating Agents
• Immunotherapy
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

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