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

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ClinicalTrials.gov Identifier: NCT03697707
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
VU University Medical Center
Information provided by (Responsible Party):
DCPrime BV

Tracking Information
First Submitted Date  ICMJE October 4, 2018
First Posted Date  ICMJE October 5, 2018
Last Update Posted Date September 18, 2019
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
minimal residual disease (MRD) [ Time Frame: up to 32 weeks ]
Any change in MRD (flow cytometric) as compared to baseline MRD
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • MRD [ Time Frame: up to 32 weeks ]
    Any change in MRD (flow cytometric) as compared to baseline MRD
  • Immune responses [ Time Frame: up to 32 weeks ]
    Any change in immunoreactivity (specific and non-specific) as compared to baseline
Change History Complete list of historical versions of study NCT03697707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
  • Treatment emergent adverse events (TEAEs) [ Time Frame: up to 56 weeks ]
    adverse event
  • Serious Adverse Events (SAEs) [ Time Frame: up to 56 weeks ]
    adverse events
  • Relapse-free survival [ Time Frame: up to 56 weeks ]
    efficacy
  • Overall survival [ Time Frame: up to 56 weeks ]
    efficacy
  • Immune responses [ Time Frame: up to 32 weeks ]
    Any change in immunoreactivity (specific and non-specific) as compared to baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • Treatment emergent adverse events (TEAEs) [ Time Frame: up to 56 weeks ]
  • Serious Adverse Events (SAEs) [ Time Frame: up to 56 weeks ]
  • Relapse-free survival [ Time Frame: up to 56 weeks ]
  • Overall survival [ Time Frame: up to 56 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia
Official Title  ICMJE 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
Brief Summary Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
First 10 patients will get the lowest dose and next 10 patients will receive the highest dose
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia in Remission
Intervention  ICMJE Biological: DCP-001
allogeneic dendritic cell vaccine
Study Arms  ICMJE
  • 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
    Intervention: Biological: DCP-001
  • 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
    Intervention: Biological: DCP-001
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Confirmed diagnosis of AML according to WHO2016 criteria, including cytological, molecular and cytogenetic criteria (except acute pro-myelocytic leukaemia/APL).
  2. 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.
  3. MRD as defined by multicolour flow cytometry (MFC) at a value of > 0.1%, or detection of specific molecular abnormalities such as NPM1 mutation.
  4. 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.
  5. Expected and willing to undergo all study procedures, including outpatient evaluations for clinical and immunological monitoring.
  6. Male or female of ≥ 18 years of age.
  7. 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 12.8 for birth control methods deemed acceptable for this study.
  8. ECOG (WHO) performance status 0-2.
  9. Willing and able to provide written informed consent for participation in the study

Exclusion Criteria:

  1. Acute Promyelocytic (APL; M3) type of AML.
  2. Patients who have undergone or are scheduled for allogeneic stem cell transplantation.
  3. History of previous allogeneic bone marrow or solid organ transplantation.
  4. Uncontrolled or serious infections
  5. Ongoing immunosuppressive therapy, other than short use of low dose steroids, i.e. equivalent to an average dose of ≤10mg of prednisone/day.
  6. Chemotherapy and antineoplastic hormonal therapy within 28 days prior to the screening visits.
  7. Active autoimmune disease.
  8. Inadequate liver function (AST and ALT > 3 x ULN, serum bilirubin >3 x ULN).
  9. 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.
  10. Pregnant or lactating females.
  11. 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.
  12. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease.
  13. 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.
  14. Known HIV, Hepatitis B and/or Hepatitis C infections.
  15. History of hypersensitivity to the investigational medicinal product or to any excipient present in the pharmaceutical form of the investigational medicinal product.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jeroen Rovers, MD, PhD +31703322627 j.rovers@dcprime.com
Contact: Rob ten Pas r.tenpas@dcprime.com
Listed Location Countries  ICMJE Germany,   Netherlands,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03697707
Other Study ID Numbers  ICMJE DCOne-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DCPrime BV
Study Sponsor  ICMJE DCPrime BV
Collaborators  ICMJE VU University Medical Center
Investigators  ICMJE
Principal Investigator: A A van de Loosdrecht, MD, PhD VU University Medical Center
PRS Account DCPrime BV
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP