- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03697707
Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia (ADVANCE-II)
October 7, 2022 updated by: Mendus
An International, Multicentre, Open-label Study To Evaluate The Efficacy and Safety of Two Different Vaccination Regimens of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia That Are In Remission With Persistent MRD
Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
International, multicentre, open-label proof of concept study exploring two different dose groups of the allogeneic dendritic cell vaccine, DCP-001.
Cohort 1 consists of 10 patients that will receive 25E6 DCP-001 cells per vaccination and Cohort 2 consists of 10 patients who will receive 50E6 DCP-001 cells per vaccination.
All patients will be given two additional booster vaccinations of 10E6 cells.
Each patient will be followed up for 12 months after the 4th vaccination.
Safety will be monitored throughout the study.
Sera and cell samples (blood and bone marrow) will be collected for assessment of efficacy (MRD evaluation) and immune response monitoring.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Helsinki, Finland
- Helsinki University Hospital
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Bonn, Germany
- Universitäts Klinikum Bonn
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Düsseldorf, Germany, D- 40479
- Marien Hospital
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Leipzig, Germany
- Universitats Klinikum Leipzig
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Mainz, Germany
- Universitätsmedizin Mainz
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Amsterdam, Netherlands
- VUmc
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Groningen, Netherlands
- UMCG
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Maastricht, Netherlands
- Maastricht University Medical Centre
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Bergen, Norway
- Haukeland Universitetssjukehus
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Uppsala, Sweden
- Uppsala University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of AML according to WHO2016 criteria, including cytological, molecular and cytogenetic criteria (except acute pro-myelocytic leukaemia/APL).
- In CR1 (first complete remission) or CRi (incomplete blood count recovery) documented by bone marrow examination up to one month before vaccination; CR defined as less than 5% blasts in normo-cellular bone marrow, ANC >1*E9/L, platelet count >100*E9/L, no evidence of extra-medullary disease. Patients in CRi (patients with <5% blasts but with incomplete blood count recovery) should have platelets >50 E9/L.
- MRD as defined by multicolour flow cytometry (MFC) at a value of > 0.1%, or detection of specific molecular abnormalities such as NPM1 mutation.
- Patients that are in CR1 or CRi. Patients not having undergone consolidation therapy must have been in CR1 for at least 1 month prior to enrolment. Patients treated with hypomethylating agents must have been given at least two cycles and up to a maximum of nine cycles of hypomethylating agents.
- Expected and willing to undergo all study procedures, including outpatient evaluations for clinical and immunological monitoring.
- Male or female of ≥ 18 years of age.
- Women of childbearing potential must be using anti-conceptive therapy or use two (2) barrier contraceptive methods (one by each partner and at least one of the barrier methods must include spermicide (unless spermicide is not approved in the country or region). See section 12.7 for birth control methods deemed acceptable for this study.
- ECOG (WHO) performance status 0-2.
- Willing and able to provide written informed consent for participation in the study
Exclusion Criteria:
- Acute Promyelocytic (APL; M3) type of AML.
- Patients who have undergone or are scheduled/eligible for allogeneic stem cell transplantation.
- History of previous allogeneic bone marrow or solid organ transplantation.
- Uncontrolled or serious infections
- Ongoing immunosuppressive therapy, other than short use of low dose steroids, i.e. equivalent to an average dose of ≤10mg of prednisone/day.
- Chemotherapy and antineoplastic hormonal therapy within 28 days prior to the screening visit, with the exception of hypomethylating agents such as azacitidine and decitabine, or midostaurin for FLT3 mutations, or patients treated with IDH12 inhibitors in mIDH1/2.
- Current or past medical history autoimmune disease.
- Inadequate liver function (AST and ALT > 3 x ULN, serum bilirubin >3 x ULN).
- Other active Malignancies within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin or adequately controlled limited basal cell skin cancer.
- Pregnant or lactating females.
- Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
- Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease.
- Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
- Known HIV, Hepatitis B and/or Hepatitis C infections.
- History of hypersensitivity to the investigational medicinal product or to any excipient present in the pharmaceutical form of the investigational medicinal product.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cohort 1: Low dose
patients receiving 4 bi-weekly vaccinations with 25E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination
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allogeneic dendritic cell vaccine
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Experimental: Cohort 2: High dose
patients receiving 4 bi-weekly vaccinations with 50E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination
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allogeneic dendritic cell vaccine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minimal residual disease (MRD)
Time Frame: up to 32 weeks
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Any change in MRD (flow cytometric) as compared to baseline MRD
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up to 32 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment emergent adverse events (TEAEs)
Time Frame: up to 56 weeks
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adverse event
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up to 56 weeks
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Serious Adverse Events (SAEs)
Time Frame: up to 56 weeks
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adverse events
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up to 56 weeks
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Relapse-free survival
Time Frame: up to 56 weeks
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efficacy
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up to 56 weeks
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Overall survival
Time Frame: up to 56 weeks
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efficacy
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up to 56 weeks
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Immune responses
Time Frame: up to 32 weeks
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Any change in immunoreactivity (specific and non-specific) as compared to baseline
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up to 32 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: A A van de Loosdrecht, MD, PhD, Amsterdam UMC, location VUmc
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2018
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
October 4, 2018
First Submitted That Met QC Criteria
October 4, 2018
First Posted (Actual)
October 5, 2018
Study Record Updates
Last Update Posted (Actual)
October 10, 2022
Last Update Submitted That Met QC Criteria
October 7, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCOne-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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