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

Affiliated Hospital to Academy of Military Medical Sciences40 enrolled

Overview

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%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndromes Dendritic Cell Hypomethylating Agents

Interventions

DC vaccineBIOLOGICAL

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

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Overall survival

Time frame: at study completion, an average of 3 years

Secondary Outcomes

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.

Time frame: at study completion, an average of 3 years

Relapse rate

Time frame: at study completion, an average of 3 years

RFS

Relapse-free survival

Time frame: at study completion, an average of 3 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts