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

Primary Purpose

Myelodysplastic Syndromes, Dendritic Cell, Hypomethylating Agents

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DC vaccine
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myelodysplastic Syndromes

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of hematologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hypomemylating agent monotherapy

Combined cellular immunotherapy（eDC）with Hypomemylating agent therapy

Arm 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)

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

Outcomes

Primary Outcome Measures

OS
Overall survival

Secondary Outcome Measures

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.
RR
Relapse rate
RFS
Relapse-free survival

Full Information

First Posted
June 30, 2021
Last Updated
August 10, 2021
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04999943
Brief Title
Hypomemylating Agents Combination With eDC Therapy for Elderly Patients With Myelodysplastic Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Dendritic Cell, Hypomethylating Agents, Immunotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypomemylating agent monotherapy
Arm Type
Active Comparator
Arm 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)
Arm Title
Combined cellular immunotherapy（eDC）with Hypomemylating agent therapy
Arm Type
Experimental
Arm 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
Intervention Type
Biological
Intervention Name(s)
DC vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
OS
Description
Overall survival
Time Frame
at study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
the Incidence of Treatment Adverse Events
Description
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
Title
RR
Description
Relapse rate
Time Frame
at study completion, an average of 3 years
Title
RFS
Description
Relapse-free survival
Time Frame
at study completion, an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elderly MDS patients; aged more than 60 years old, general condition, ECOG score less than 1; normal function of heart, liver and kidney, serum bilirubin ≤ 35 umol / L; serum creatinine ≤ 150 umol / L; patients are unsuitable or unwilling to receive hematopoietic stem cell transplantation; subjects sign informed consent. Exclusion criteria: serious infection was not controlled before treatment; contraindications for the use of dexitabine and azacytidine; other cases that did not meet the admission criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Sun, M.D., Ph. D.
Phone
010-66947402
Email
suny320@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxin Wang, M.D.
Phone
010-66947109
Email
wyx15147159987@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangding Hu, Prof.
Organizational Affiliation
the Fifth Medical Center the PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of hematology
City
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Yao, M.D., Ph.D.
Phone
+86-010-6694-7402
Email
suny320@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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