Myelodysplastic SyndromesPhase 1eDC-MDSNCT04999943
Hypomemylating Agents Combination With eDC Therapy for Elderly Patients With Myelodysplastic Syndrome
A Phase 1 study testing DC vaccine in people with Myelodysplastic Syndromes and Dendritic Cell, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Dendritic Cell, Hypomethylating Agents
- What is being tested?
- DC vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- serious infection was not controlled before treatment;
- contraindications for the use of dexitabine and azacytidine;
- other cases that did not meet the admission criteria.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of hematology
Beijing, 100071
Sun Yao, M.D., Ph.D., +86-010-6694-7402, suny320@126.com
About this study
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
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.
Read the 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%.
- Being tested
- DC vaccine
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Biological: DC vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival
Measured: at study completion, an average of 3 years
Secondary outcomes (3)
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.
Measured: at study completion, an average of 3 years
RR
Relapse rate
Measured: at study completion, an average of 3 years
RFS
Relapse-free survival
Measured: at study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangding Hu, Prof., Study chair, the Fifth Medical Center the PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999943
- Sponsor's protocol ID
- 2107-Hem-1-eDC
- Acronym
- eDC-MDS
- Status last verified
- Aug 2021
- First submitted
- 30 Jun 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04999943
- Acronym / sponsor ID
- eDC-MDS / 2107-Hem-1-eDC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypomemylating agent monotherapy | Active comparator | Biological: DC vaccineAzacitidine 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 | Experimental | Biological: DC vaccineAzacitidine 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- serious infection was not controlled before treatment;
- contraindications for the use of dexitabine and azacytidine;
- other cases that did not meet the admission criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC vaccineEDC 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. | Biological | Combined cellular immunotherapy（eDC）with Hypomemylating agent therapy, Hypomemylating agent monotherapy |
Primary outcome
OS
Time frame: at study completion, an average of 3 years
Overall survival
3 secondary outcomes
the Incidence of Treatment Adverse Events
Time frame: at study completion, an average of 3 years
RR
Time frame: at study completion, an average of 3 years
RFS
Time frame: at study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
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RecruitingPhase 2
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Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liangding Hu, Prof. study chair
the Fifth Medical Center the PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DC vaccine in people with Myelodysplastic Syndromes and Dendritic Cell, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao Sun, M.D., Ph. D. (010-66947402, suny320@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: at study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.