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 leukemia that are in remission with persistent MRD.
- Conditions
- Acute Myeloid LeukemiaBlood cancer10024324
- Registration Number
- NL-OMON52641
- Lead Sponsor
- Immunicum AB (voorheen DCprime bv)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
1. Confirmed diagnosis of AML according to WHO2016 criteria, including
cytological, molecular and cytogenetic criteria (except acute promyelocytic
leukemia/APL).
2. In CR1 or CRi 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*10E9/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 G/L.
3. MRD as defined by multicolor 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 or CRi 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.
5. Expected to be willing and able to undergo all study procedures, including
outpatient evaluations for clinical and immunological monitoring.
6. Male or female > 18 years of age.
7. Women of childbearing potential must be on anti-conceptive therapy, or using
an intrauterine device, 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), or underwent
tubal ligation, or the partner was vasectomized, or is sexually abstinent.
8. ECOG (WHO) performance status 0-2.
9. Willing and able to provide written informed consent for participation in
the study and for tissue sample biobanking..
1. APL (M3) type of AML.
2. Patients who have undergone or are scheduled/eligible 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 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 IDH1/2 inhibitors in mIDH1/2.
7. Current or past medical history of autoimmune disease.
8. Inadequate liver function (AST and ALT > 3 x ULN, serum bilirubin >3x 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 or 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Any change in MRD (flow cytometric) as compared to baseline MRD<br /><br>- Any change in immunoreactivity (specific and non-specific) as compared to<br /><br>baseline.</p><br>
- Secondary Outcome Measures
Name Time Method