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 : Active, not recruiting
First Posted : October 5, 2018
Last Update Posted : October 10, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia in Remission||Biological: DCP-001||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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)|
|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|
|Actual Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||December 2025|
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
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
allogeneic dendritic cell vaccine
- minimal residual disease (MRD) [ Time Frame: up to 32 weeks ]Any change in MRD (flow cytometric) as compared to baseline MRD
- 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
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|
- 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
- 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.
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
|Helsinki University Hospital|
|Universitats Klinikum Bonn|
|Düsseldorf, Germany, D- 40479|
|Universitats Klinikum Leipzig|
|Maastricht University Medical Centre|
|Uppsala University Hospital|
|Principal Investigator:||A A van de Loosdrecht, MD, PhD||Amsterdam UMC, location VUmc|
|Other Study ID Numbers:||
|First Posted:||October 5, 2018 Key Record Dates|
|Last Update Posted:||October 10, 2022|
|Last Verified:||October 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
AML in CR1 or CRi
Minimal Residual Disease
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type