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Acute Myeloid Leukemia in RemissionPhase 2ADVANCE-IINCT03697707

Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia

A Phase 2 study testing DCP-001 in people with Acute Myeloid Leukemia in Remission, run by Mendus at 10 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia in Remission
What is being tested?
DCP-001
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
10 sitesin 5 countries
Study dates
15 Oct 2018to Dec 2025
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

10 sites in 5 countries.

10 sites in 5 countries

Germany4 sites

  • Universitats Klinikum Bonn

    Bonn

  • Marien Hospital

    Düsseldorf, D- 40479

  • Universitats Klinikum Leipzig

    Leipzig

  • Universitätsmedizin Mainz

    Mainz

Other trials in Germany

Netherlands3 sites

  • VUmc

    Amsterdam

  • UMCG

    Groningen

  • Maastricht University Medical Centre

    Maastricht

Other trials in Netherlands

Finland1 site

  • Helsinki University Hospital

    Helsinki

Other trials in Finland

Norway1 site

  • Haukeland universitetssjukehus

    Bergen

Other trials in Norway

Sweden1 site

  • Uppsala University Hospital

    Uppsala

Other trials in Sweden

About this study

Official title: 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

Read the 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.

Being tested
DCP-001
Keywords
AML in CR1 or CRi, DCOne, DCP-001, Minimal Residual Disease
Medical subject headings
Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCP-001Biological

    allogeneic dendritic cell vaccine

Study groups in NCT03697707
Study groupRoleWhat they receive
Cohort 1: Low doseExperimentalpatients receiving 4 bi-weekly vaccinations with 25E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination
Receives: Biological: DCP-001
Cohort 2: High doseExperimentalpatients receiving 4 bi-weekly vaccinations with 50E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination
Receives: Biological: DCP-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. minimal residual disease (MRD)

    Any change in MRD (flow cytometric) as compared to baseline MRD

    Measured: up to 32 weeks

Secondary outcomes (5)

  1. Treatment emergent adverse events (TEAEs)

    adverse event

    Measured: up to 56 weeks

  2. Serious Adverse Events (SAEs)

    adverse events

    Measured: up to 56 weeks

  3. Relapse-free survival

    efficacy

    Measured: up to 56 weeks

  4. Overall survival

    efficacy

    Measured: up to 56 weeks

  5. Immune responses

    Any change in immunoreactivity (specific and non-specific) as compared to baseline

    Measured: up to 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start15 Oct 2018
  3. Primary completionMar 2023 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
First 10 patients will get the lowest dose and next 10 patients will receive the highest dose
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03697707
Sponsor's protocol ID
DCOne-002
Acronym
ADVANCE-II
Status last verified
Oct 2022
First submitted
4 Oct 2018
Last updated
10 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • van de Loosdrecht AA, van Wetering S, Santegoets SJAM, Singh SK, Eeltink CM, den Hartog Y, Koppes M, Kaspers J, Ossenkoppele GJ, Kruisbeek AM, de Gruijl TD. A novel allogeneic off-the-shelf dendritic cell vaccine for post-remission treatment of elderly patients with acute myeloid leukemia. Cancer Immunol Immunother. 2018 Oct;67(10):1505-1518. doi: 10.1007/s00262-018-2198-9. Epub 2018 Jul 23.

    PubMed 30039426

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DCP-001 in people with Acute Myeloid Leukemia in Remission, run by Mendus at 10 sites in 5 countries.

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 9 inclusion and 15 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 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Netherlands, Finland, Norway, Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

minimal residual disease (MRD) (time frame: up to 32 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03697707, which also lists 1 linked publication.

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 10 Oct 2022.

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