Hypomemylating Agents Combination With eDC Therapy for Elderly Patients With Myelodysplastic Syndrome (eDC-MDS)

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase: Enrolling; Phase 1

Conditions: Hypomethylating Agents; Immunotherapy; Dendritic Cell; Myelodysplastic Syndromes

Treatments: Biological: DC vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT04999943

2107-Hem-1-eDC

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 40 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Hypomemylating agent monotherapy

Active Comparator group

Description:

Azacitidine 100mg/ times. d × for 10 days (28 days for one cycle) or Decitabine 25mg/ times. d × 5 days ( 28 days is one cycle)

Treatment:

Biological: DC vaccine

Combined cellular immunotherapy（eDC）with Hypomemylating agent therapy

Experimental group

Description:

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

Treatment:

Biological: DC vaccine