Acute Myeloid LeukemiaNCT05000801
Clinical Study of DC-AML Cells in the Treatment of Acute Myeloid Leukemia
A study testing DC vaccine in people with Acute Myeloid Leukemia, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
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 acute myeloid leukemia (AML) patients by eradicating minimal residual disease, while maintaining its… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- DC vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jul 2026
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).
- Patients completed induction and consolidation chemotherapy and have achieved complete remission (CR) by bone marrow biopsy criteria but with persistent MRD (defined by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) and are not eligible for stem cell transplant
- Patients have MRD molecular relapse (defined by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) after achieved CR following induction and consolidation chemotherapy.
- Patients with molecular relapse (define by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) after allogeneic stem cell transplant
- Leukemic cells express at least one of the following antigens: WT1, hTERT or survivin detected by qRT-PCR and/or flow cytometry or immunohistochemistry
- Karnofsky PS ≥60% or ECOG PS≤2.
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- Patients must have organ and marrow function as defined below:
- leukocytes >=3,000/mcL
- absolute neutrophil count >=1,500/mcL
- platelets >=100,000/mcL
- hemoglobin >=9.0 g/dL
- total bilirubin within normal institutional limits except in patients with Gilberts Syndrome who must have a total bilirubin < 3.0 mg/dL
- AST(SGOT)/ALT(SGPT) Serum ALT/AST < 2.5X ULN
- creatinine clearance Calculated creatinine clearance (CrCl) >=50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
- Adequate cardiac function: LVEF ≥50% by MUGA
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participation in any other interventional clinical trial during the study period.
- History or concomitant presence of any other malignancy, except for any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment.
- Patients with a second invasive malignancy requiring treatment within the last 2 years are not eligible.
- Patients with any form of systemic immunodeficiency, including AIDS or primary immunodeficiency such as Severe Combined Immunodeficiency Disease, are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the treatment.
- Active hepatitis B, C infection
- Patients on immunosuppressive drugs including corticosteroids.
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- Patients with autoimmune diseases such as Crohn s disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements.
- Allergic to human albumin or IL-2. History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
- Pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of hematology
Beijing, Beijing Municipality, 100071
Sun Yao, M.D.,Ph.D., +86-010-6694-7402, suny320@126.com
About this study
Official title: Safety and Feasibility Study of Dendritic Cell (DC) Vaccination Expressing WT1/hTERT/Survivin in AML Patients With Minimal Residual Disease (MRD)
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 acute myeloid leukemia (AML) patients by eradicating minimal residual disease, while maintaining its safety profile in this phase I trial.
Read the detailed description
we will conduct a single-arm phase I clinical study in 20 patients with acute myeloid leukemia (AML) at the stage of minimal residual disease (MRD) following standard chemotherapy, and these patients are not the subjects of stem cell transplantation. Adult patients between18 and 70 years old with AML who have entered morphological remission after induction, consolidation or intensive chemotherapy with molecular signature of increased WT1 molecule levels and pathological characteristics of bone marrow biopsy, together with fulfilling all other eligibility criteria, will be vaccinated with dendritic cells loaded with tri-antigens (WT1/TERT/survivin) in the absence of any additional therapeutic measurements. The primary aim of this innovative immunotherapy study is to determine whether the anti-leukemic effects seen in our preclinical study can be confirmed in patients and whether such DC vaccination can significantly prevent relapse and increase survival of AML patients by eradicating minimal residual disease. Patients will be recruited at 307 Hospital in Beijing. Recruitment will start in the second half of 2021 and will last for two years or until 20 safety and efficacy-evaluable AML patients are included. This is a single-arm trial. The patients who present MRD after complete chemotherapy will receive a conditioning regimen of cyclophosphamide, followed by six infusions of autologous or HLA-matched donor-derived DCs loaded with tri-antigens including WT1/TERT/survivin. The dendritic cell therapy product will be administered in the stem cell transplantation center at 307 Hospital headed by Dr. Liang-Ding Hu. After inclusion of 20 safety/feasibility-evaluable patients, relapse rate, relapse-free survival and overall survival analysis will be performed. Tumor marker levels and immune signature molecules will also be monitored at molecular and immunological levels, and general and disease-specific quality of life will be evaluated using quality of life questionnaires at various time points.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- DC vaccine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC vaccineBiological
Autologous/or HLA-matched donors' DCs loaded with WT1/TERT/survivin
| Study group | Role | What they receive |
|---|---|---|
| DC vaccine | Experimental | Vaccination with autologous or HLA-matched donors' WT1/TERT/survivin loaded DCs plus follow-up care. Receives: Biological: DC vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Incidence of Treatment Adverse Events
To determine the safety of autologous/or HLA-matched DCs loaded with WT1/TERT/Survivin. The primary objective of this single-arm phase I clinical study is to determine the safety and feasibility of WT1/TERT/survivin-targeted DC vaccination in adult AML patients with MRD at very high risk of relapse.
Measured: through study completion,an average of 3 years
Secondary outcomes (5)
OS
Overall survival
Measured: through study completion,an average of 3 years
Complete MRD response rate
To determine the Complete MRD response rate
Measured: through study completion,an average of 3 years
Relapse rate
(time frame: at study completion, an average of 5 year)
Measured: through study completion,an average of 3 years
Relapse-free survival
(time frame: at study completion, an average of 5 year)
Measured: through study completion,an average of 3 years
Change in WT1 mRNA levels from peripheral blood samples and/or bone marrow biopsy samples.
Efficacy assessment will also be performed on a molecular level. Bone marrow biopsy samples obtained from participants will be examined, and part of samples will be analyzed by qRT-PCR for WT1 expression.
Measured: through 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 Acute Myeloid LeukemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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, M.D., Study director, the Fifth Medical Center the PLA General HospitalLiangding Hu, M.D., Principal investigator, the Fifth Medical Center the PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000801
- Sponsor's protocol ID
- 307-DC-1911
- Status last verified
- Aug 2021
- First submitted
- 13 Jul 2021
- Last updated
- 20 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 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of Dendritic Cell (DC) Vaccination Expressing WT1/hTERT/Survivin in AML Patients With Minimal Residual Disease (MRD)
- ClinicalTrials.gov ID
- NCT05000801
- Acronym / sponsor ID
- 307-DC-1911
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 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 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 acute myeloid leukemia (AML) patients by eradicating minimal residual disease, while maintaining its safety profile in this phase I trial.
Detailed description
we will conduct a single-arm phase I clinical study in 20 patients with acute myeloid leukemia (AML) at the stage of minimal residual disease (MRD) following standard chemotherapy, and these patients are not the subjects of stem cell transplantation. Adult patients between18 and 70 years old with AML who have entered morphological remission after induction, consolidation or intensive chemotherapy with molecular signature of increased WT1 molecule levels and pathological characteristics of bone marrow biopsy, together with fulfilling all other eligibility criteria, will be vaccinated with dendritic cells loaded with tri-antigens (WT1/TERT/survivin) in the absence of any additional therapeutic measurements. The primary aim of this innovative immunotherapy study is to determine whether the anti-leukemic effects seen in our preclinical study can be confirmed in patients and whether such DC vaccination can significantly prevent relapse and increase survival of AML patients by eradicating minimal residual disease. Patients will be recruited at 307 Hospital in Beijing. Recruitment will start in the second half of 2021 and will last for two years or until 20 safety and efficacy-evaluable AML patients are included. This is a single-arm trial. The patients who present MRD after complete chemotherapy will receive a conditioning regimen of cyclophosphamide, followed by six infusions of autologous or HLA-matched donor-derived DCs loaded with tri-antigens including WT1/TERT/survivin. The dendritic cell therapy product will be administered in the stem cell transplantation center at 307 Hospital headed by Dr. Liang-Ding Hu. After inclusion of 20 safety/feasibility-evaluable patients, relapse rate, relapse-free survival and overall survival analysis will be performed. Tumor marker levels and immune signature molecules will also be monitored at molecular and immunological levels, and general and disease-specific quality of life will be evaluated using quality of life questionnaires at various time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC vaccine | Experimental | Biological: DC vaccineVaccination with autologous or HLA-matched donors' WT1/TERT/survivin loaded DCs plus follow-up care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).
- Patients completed induction and consolidation chemotherapy and have achieved complete remission (CR) by bone marrow biopsy criteria but with persistent MRD (defined by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) and are not eligible for stem cell transplant
- Patients have MRD molecular relapse (defined by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) after achieved CR following induction and consolidation chemotherapy.
- Patients with molecular relapse (define by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) after allogeneic stem cell transplant
- Leukemic cells express at least one of the following antigens: WT1, hTERT or survivin detected by qRT-PCR and/or flow cytometry or immunohistochemistry
Key exclusion criteria (10 listed)
- Participation in any other interventional clinical trial during the study period.
- History or concomitant presence of any other malignancy, except for any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment.
- Patients with a second invasive malignancy requiring treatment within the last 2 years are not eligible.
- Patients with any form of systemic immunodeficiency, including AIDS or primary immunodeficiency such as Severe Combined Immunodeficiency Disease, are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the treatment.
- Active hepatitis B, C infection
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 vaccineAutologous/or HLA-matched donors' DCs loaded with WT1/TERT/survivin | Biological | DC vaccine |
Primary outcome
the Incidence of Treatment Adverse Events
Time frame: through study completion,an average of 3 years
To determine the safety of autologous/or HLA-matched DCs loaded with WT1/TERT/Survivin. The primary objective of this single-arm phase I clinical study is to determine the safety and feasibility of WT1/TERT/survivin-targeted DC vaccination in adult AML patients with MRD at very high risk of relapse.
5 secondary outcomes
OS
Time frame: through study completion,an average of 3 years
Complete MRD response rate
Time frame: through study completion,an average of 3 years
Relapse rate
Time frame: through study completion,an average of 3 years
Relapse-free survival
Time frame: through study completion,an average of 3 years
Change in WT1 mRNA levels from peripheral blood samples and/or bone marrow biopsy samples.
Time frame: through 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 20 Aug 2021.
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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, M.D. study director
the Fifth Medical Center the PLA General Hospital
Liangding Hu, M.D. principal investigator
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 study testing DC vaccine in people with Acute Myeloid Leukemia, 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 16 inclusion and 10 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 20 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.
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 Sun Yao, 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?
the Incidence of Treatment Adverse Events (time frame: through 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 20 Aug 2021.