Acute Myeloid Leukemia Blood cancer
Conditions
Interventions
Patients will receive 25E6 DCP-001 cells per vaccination (Group 1
10 patients)
or 50E6 DCP-001 cells (Group 2
10 patients) per vaccination. Both groups will
receive two additional booster vaccination of 10E6 cells.
The first treatment for both dose groups is given at Day 0 (Baseline), the
second, third and
Sponsors
Immunicum AB (voorheen DCprime bv)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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 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..
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Any change in MRD (flow cytometric) as compared to baseline MRD - Any change in immunoreactivity (specific and non-specific) as compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints - To document safety and tolerability. - To quantify any lag time between initiation of treatment & onset of effect. - To determine the effect of DCP-001 on Time to Relapse (TTR). - To determine the effect of DCP-001 on Overall Survival (OS). - To document the difference between the two vaccination regimens based on MRD outcome and immunological parameters. Exploratory Endpoints - To document the number and duration of subsequent remissions. - To identify subgroups of patients most likely to benefit from treatment. - To identify surrogate (immunological) markers that might correlate with clinical outcome. - To quantify any lag time between initiation of treatment & onset of effect - To identify surrogate (immunological) markers that might correlate with clinical outcome. Safety endpoints: - Treatment emergent adverse events (TEAEs) will be collected in first 48 hours after the first vaccination to determine (acute) toxicity due to intradermal injection. - All TEAEs will be collected during the study period for each patient and the grade of toxicity (CTCAE v.4.0, see Appendix B) and relationship to product determined. - A DSMB will meet after every 5 patients complete treatment to evaluate safety; written reports will be made of each meeting. - All SAEs will be reported by the investigator within 24 hours of the first knowledge. All SAEs will be reported in a timely manner to the appropriate regulatory body, consistent with existing regulations. Information on relevant SAEs will be disseminated between sites in a timely manner. Processes are described in detail in the study specific safety plan. | — |
Countries
Netherlands
Outcome results
None listed