Dual Vaccine Trial in Myeloproliferative Neoplasms

  • STATUS
    Recruiting
  • End date
    Jul 10, 2022
  • participants needed
    48
  • sponsor
    Inge Marie Svane
Updated on 23 January 2021
myeloproliferative disorder
polycythemia vera
essential thrombocythemia
thrombocytosis
pd-l1 peptide

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 safety, toxicity and clinical effect.

Details
Condition ESSENTIAL THROMBOCYTHEMIA, Polycythemia Vera
Treatment PD-L1 peptide: PD-L1 Long(19-27) Peptide sequence: FMTYWHLLNAFTVTVPKDL, Arginase1 peptide: ArgLong2(169-206) Peptide sequence ISAKDIVYIGLRDVDPGEHYILKTLGIKYFSMTEVDRL
Clinical Study IdentifierNCT04051307
SponsorInge Marie Svane
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: ESSENTIAL THROMBOCYTHEMIA or Polycythemia Vera?
\. 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 mol/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
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
Clear my responses

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