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

NCT03697707 | Unknown Phase 2 DMC

• 1 other identifier: DCOne-002
• Study Type: interventional
• Target: 20
• Locations: 5 countries
• Sites: 10

Brief Summary

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

Conditions

Acute Myeloid Leukemia in Remission

Keywords

AML in CR1 or CRi; DCOne; DCP-001; Minimal Residual Disease

Outcome Measures

Primary Outcomes (1)

• minimal residual disease (MRD)

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

  up to 32 weeks

Secondary Outcomes (5)

• Treatment emergent adverse events (TEAEs)

  up to 56 weeks

• Serious Adverse Events (SAEs)

  up to 56 weeks

• Relapse-free survival

  up to 56 weeks

• Overall survival

  up to 56 weeks

• Immune responses

  up to 32 weeks

Study Arms (2)

Cohort 1: Low dose

EXPERIMENTAL

patients receiving 4 bi-weekly vaccinations with 25E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination

Biological: DCP-001

Cohort 2: High dose

EXPERIMENTAL

patients receiving 4 bi-weekly vaccinations with 50E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination

Biological: DCP-001

Interventions

DCP-001 BIOLOGICAL

allogeneic dendritic cell vaccine

Cohort 1: Low dose; Cohort 2: High dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mendus: lead
• Amsterdam UMC, location VUmc: collaborator

Study Sites (10)

Helsinki University Hospital

Helsinki, Finland

Location

Universitats Klinikum Bonn

Bonn, Germany

Location

Marien Hospital

Düsseldorf, D- 40479, Germany

Location

Universitats Klinikum Leipzig

Leipzig, Germany

Location

Universitätsmedizin Mainz

Mainz, Germany

Location

VUmc

Amsterdam, Netherlands

Location

UMCG

Groningen, Netherlands

Location

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Haukeland universitetssjukehus

Bergen, Norway

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (1)

• 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.

  PMID: 30039426 BACKGROUND

MeSH Terms

Conditions

Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• A A van de Loosdrecht, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First 10 patients will get the lowest dose and next 10 patients will receive the highest dose

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 5, 2018
• Study Start: October 15, 2018
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2025
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

NL (3); NO (1); DE (4); SE (1); FI (1)