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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myelodysplastic Syndromes; Immunotherapy; Dendritic Cell; Hypomethylating Agents
• Intervention / Treatment: Biological: DC vaccine

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yao Sun, M.D., Ph. D.; Phone Number: 010-66947402; Email: suny320@126.com
• Study Contact Backup: Name: Yuxin Wang, M.D.; Phone Number: 010-66947109; Email: wyx15147159987@163.com

Study Locations

• China
  • Beijing, China, 100071
    • Recruiting
    • Department of Hematology
    • Contact: Sun Yao, M.D., Ph.D.; Phone Number: +86-010-6694-7402; Email: suny320@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hypomemylating agent monotherapy; Azacitidine 100mg/ times. d × for 10 days (28 days for one cycle) or Decitabine 25mg/ times. d × 5 days ( 28 days is one cycle)	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.
Experimental: Combined cellular immunotherapy（eDC）with Hypomemylating agent therapy; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	at study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
RR	Relapse rate	at study completion, an average of 3 years
RFS	Relapse-free survival	at study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Study Chair: Liangding Hu, Prof., the Fifth Medical Center the PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): July 1, 2026
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: 2107-Hem-1-eDC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No