Status:
COMPLETED
Dual Vaccine Trial in Myeloproliferative Neoplasms
Lead Sponsor:
Inge Marie Svane
Conditions:
Polycythemia Vera
Essential Thrombocythemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A phase I-II study in patients with mutated MPN by vaccinating with PD-L1 and Aginase1 peptides with Montanide ISA-51 as adjuvant, to monitor the immunological response to vaccination and subsequently...
Eligibility Criteria
Inclusion
- 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 6. Creatinine \< 2.5 upper normal limit, i.e. \< 300 µmol/l 7. Sufficient liver function, i.e.
- ALAT \< 2.5 upper normal limit, i.e. ALAT \<112 U/l
- Bilirubin \< 30 U/l 8. For women: Agreement to use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 120 days after the last treatment.
- 9\. For men: Agreement to use contraceptive measures and agreement to refrain from donating sperm.
- Exclusion criteria
- 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.
- Significant medical condition per investigators judgement e.g. severe Asthma/COPD, poorly regulated heart condition, insulin dependent diabetes mellitus.
- Acute or chronic viral or bacterial infection e.g. HIV, hepatitis or tuberculosis
- Serious known allergies or earlier anaphylactic reactions.
- Known sensibility to Montanide ISA-51
- 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.
- Pregnant and breastfeeding women.
- Fertile women not using secure contraception with a failure rate less than \< 1%
- Patients taking immune suppressive medications incl. systemic corticosteroids and methotrexate at the time of enrollment
- Psychiatric disorders that per investigator judgment could influence compliance.
- Treatment with other experimental drugs
- Treatment with other anti-cancer drugs - except IFN-a, hydroxyurea or anagrelide.
- Treatment with ruxolitinib.
- Treatment with chemotherapy or immune therapy (excluding IFN-a, hydroxyurea or anagrelide) within the last 28 days.
Exclusion
Key Trial Info
Start Date :
July 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04051307
Start Date
July 10 2019
End Date
July 10 2022
Last Update
July 13 2023
Active Locations (2)
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1
Herlev Hospital
Herlev, Capital Region, Denmark, 2730
2
National Center for Cancer Immune Therapy (CCIT-DK)
Herlev, Denmark, 2730