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

NCT04999943 | Recruiting Phase 1

• 1 other identifier: 2107-Hem-1-eDC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndromes; Dendritic Cell; Hypomethylating Agents; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• OS

  Overall survival

  at study completion, an average of 3 years

Secondary Outcomes (3)

• the Incidence of Treatment Adverse Events

  at study completion, an average of 3 years

• RR

  at study completion, an average of 3 years

• RFS

  at study completion, an average of 3 years

Study Arms (2)

Hypomemylating agent monotherapy

ACTIVE COMPARATOR

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

Combined cellular immunotherapy（eDC）with Hypomemylating agent therapy

EXPERIMENTAL

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

Interventions

DC vaccine BIOLOGICAL

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.

Combined cellular immunotherapy（eDC）with Hypomemylating agent therapy; Hypomemylating agent monotherapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• serious infection was not controlled before treatment;
• contraindications for the use of dexitabine and azacytidine;
• other cases that did not meet the admission criteria.

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

Department of hematology

Beijing, 100071, China

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Liangding Hu, Prof.

  the Fifth Medical Center the PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Yao Sun, M.D., Ph. D.

CONTACT

010-66947402; suny320@126.com

Yuxin Wang, M.D.

CONTACT

010-66947109; wyx15147159987@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 11, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 11, 2021

Record last verified: 2021-08

Locations

CN (1)