Myeloproliferative Neoplasms MedDRA version: 20.1 Level: LLT Classification code 10028576 Term: Myeloproliferative disorder System Organ Class: 100000004864 MedDRA version: 20.1 Level: LLT Classification code 10036061 Term: Polycythemia vera System Organ Class: 100000004864 MedDRA version: 20.1 Level: LLT Classification code 10015494 Term: Essential thrombocythemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: ARGLong2
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: MONTANIDE ISA51
CAS Number: 190396-06-6
Other descriptive name: MONTANIDE ISA51
Conc
Sponsors
Department of haematology, Zealand university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of essential thrombocythemia or Polycythemia Vera, according to the WHO criteria123,124 2. Age =18 years 3. Performance status = 2 (ECOG-scale) 4. Expected survival > 3 months 5. Sufficient bone marrow function, i.e. a. Leucocytes = 1,5 x 109 b. Granulocytes = 1,0 x 109 c. Thrombocytes = 20 x 109 d. Hemoglobin = 5.5 mmol/L 6. Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Other malignancies in the medical history excluding basal cell carcinoma. Patients cured for another malignant disease with no sign of relapse five years after ended treatment is allowed to enter the protocol. 2. Significant medical condition per investigators judgement e.g. severe Asthma/COPD, poorly regulated heart condition, insulin dependent diabetes mellitus. 3. Acute or chronic viral or bacterial infection e.g. HIV, hepatitis or tuberculosis 4. Serious known allergies or earlier anaphylactic reactions. 5. Known sensibility to Montanide ISA-51 6. Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc. 7. Pregnant and breastfeeding women. 8. Fertile women not using secure contraception with a failure rate less than < 1% 9. Patients taking immune suppressive medications incl. systemic corticosteroids and methotrexate at the time of enrollment 10. Psychiatric disorders that per investigator judgment could influence compliance. 11. Treatment with other experimental drugs 12. Treatment with other anti-cancer drugs – except IFN-a, hydroxyurea or anagrelide. 13. Treatment with ruxolitinib. 14. Treatment with chemotherapy or immune therapy (excluding IFN-a, hydroxyurea or anagrelide) within the last 28 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We will conduct a phase I-II study in patients with mutated MPN by vaccinating with PD-L1 and ARGLong2 peptides with Montanide ISA-51 (Seppic Inc., Paris, France) as adjuvant, to monitor the immunological response to vaccination and subsequently safety and toxicity. ;Secondary Objective: safety and toxicity. ;Primary end point(s): Immunogenicity of the two peptides-vaccines. ;Timepoint(s) of evaluation of this end point: After 3-6-7-9-12 vaccine rounds | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and toxicity, clinical effect of the vaccine will be described;Timepoint(s) of evaluation of this end point: At all timepoints | — |
Countries
Denmark
Contacts
Public ContactJacob Grauslund
Center for cancer immunetherapy, Dept. of Hematology, Herlev hospital
Outcome results
None listed