ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03697707
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03697707
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
VU University Medical Center
Information provided by (Responsible Party):
DCPrime BV

Brief Summary:
Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia in Remission Biological: DCP-001 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 20 participants
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
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
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
Biological: DCP-001
allogeneic dendritic cell vaccine

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
Biological: DCP-001
allogeneic dendritic cell vaccine




Primary Outcome Measures :
  1. minimal residual disease (MRD) [ Time Frame: up to 32 weeks ]
    Any change in MRD (flow cytometric) as compared to baseline MRD


Secondary Outcome Measures :
  1. Treatment emergent adverse events (TEAEs) [ Time Frame: up to 56 weeks ]
    adverse event

  2. Serious Adverse Events (SAEs) [ Time Frame: up to 56 weeks ]
    adverse events

  3. Relapse-free survival [ Time Frame: up to 56 weeks ]
    efficacy

  4. Overall survival [ Time Frame: up to 56 weeks ]
    efficacy

  5. Immune responses [ Time Frame: up to 32 weeks ]
    Any change in immunoreactivity (specific and non-specific) as compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697707


Contacts
Contact: Jeroen Rovers, MD, PhD +31703322627 j.rovers@dcprime.com
Contact: Rob ten Pas r.tenpas@dcprime.com

Locations
Germany
Universitats Klinikum Bonn Not yet recruiting
Bonn, Germany
Contact: principal investigator         
Netherlands
VUmc Recruiting
Amsterdam, Netherlands
Contact: principal investigator         
UMCG Recruiting
Groningen, Netherlands
Contact: principal investigator         
Sponsors and Collaborators
DCPrime BV
VU University Medical Center
Investigators
Principal Investigator: A A van de Loosdrecht, MD, PhD VU University Medical Center

Publications:
Responsible Party: DCPrime BV
ClinicalTrials.gov Identifier: NCT03697707     History of Changes
Other Study ID Numbers: DCOne-002
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DCPrime BV:
AML in CR1 or CRi
DCOne
DCP-001
Minimal Residual Disease

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs