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

Phase 1

Recruiting

• Conditions: Dendritic Cell; Immunotherapy; Myelodysplastic Syndromes; Hypomethylating Agents
• Interventions: Biological: DC vaccine

• Registration Number: NCT04999943
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief 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.

Detailed 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%.

Study Timeline

• Study First Submitted: 2021-06-30
• Study Start: 2021-07-01
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-10
• Last Update Submitted: 2021-08-10
• Study First Posted: 2021-08-11
• Last Update Posted: 2021-08-11
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypomemylating agent monotherapy	DC vaccine	Azacitidine 100mg/ times. d × for 10 days (28 days for one cycle) or Decitabine 25mg/ times. d × 5 days ( 28 days is one cycle)
Combined cellular immunotherapy（eDC）with Hypomemylating agent therapy	DC vaccine	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

Primary Outcome Measures

Name	Time	Method
OS	at study completion, an average of 3 years	Overall survival

Secondary Outcome Measures

Name	Time	Method
RR	at study completion, an average of 3 years	Relapse rate
the Incidence of Treatment Adverse Events	at study completion, an average of 3 years	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.
RFS	at study completion, an average of 3 years	Relapse-free survival

Trial Locations

Locations (1)

Department of hematology; 🇨🇳 Beijing, China