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Dual Vaccine Trial in Myeloproliferative Neoplasms

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ClinicalTrials.gov Identifier: NCT04051307
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital

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 safety, toxicity and clinical effect.

Condition or disease Intervention/treatment Phase
Polycythemia Vera Essential Thrombocythemia Drug: PD-L1 peptide: PD-L1 Long(19-27) Peptide sequence: FMTYWHLLNAFTVTVPKDL Drug: Arginase1 peptide: ArgLong2(169-206) Peptide sequence ISAKDIVYIGLRDVDPGEHYILKTLGIKYFSMTEVDRL Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dual Vaccine Trial in Myeloproliferative Neoplasms
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : July 10, 2022
Estimated Study Completion Date : July 10, 2022


Arm Intervention/treatment
Experimental: intervention

Vaccination with:

PD-L1 peptide:

PD-L1 Long(19-27) Peptide sequence: FMTYWHLLNAFTVTVPKDL Dose: 100 µg PD-L1 long1 dissolved in DMSO/water - Total volume: 0,5 ml.

Arginase1 peptide:

ArgLong2(169-206) Peptide sequence ISAKDIVYIGLRDVDPGEHYILKTLGIKYFSMTEVDRL Dose: 200 µg ARGLong2 dissolved in DMSO/water - Total volume: 0,5 ml.

Both vaccines are given at a treatment. Adjuvant Montanide ISA 51 0,5ml is mixed with the peptides before treatment To be administered every second week - a total of twelve times, with a possibility of additional six treatments.

Drug: PD-L1 peptide: PD-L1 Long(19-27) Peptide sequence: FMTYWHLLNAFTVTVPKDL
Peptide vaccination
Other Name: PD-L1Long

Drug: Arginase1 peptide: ArgLong2(169-206) Peptide sequence ISAKDIVYIGLRDVDPGEHYILKTLGIKYFSMTEVDRL
Peptide vaccination
Other Name: ARGLong2




Primary Outcome Measures :
  1. Immune response [ Time Frame: 1 year ]
    T-cell cytokine release towards target antigens


Secondary Outcome Measures :
  1. Adverse events evaluated by CTCAE v. 5.0 [ Time Frame: 1 year ]
    Adverse events are graded 1-5 according to the criteria

  2. Clinical response [ Time Frame: 10 year ]
    Vaccinations will induce clinical response in 2 patients, either partial response or better, according response criteria for PV and ET or clinical response as a reduction of mutated allelic burden - 10% from baseline at any time.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 6. Creatinine < 2.5 upper normal limit, i.e. < 300 µmol/l 7. Sufficient liver function, i.e.

    1. ALAT < 2.5 upper normal limit, i.e. ALAT <112 U/l
    2. 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

      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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051307


Contacts
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Contact: Jacob H Grauslund, MD +4538688961 jgra0033@regionh.dk

Locations
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Denmark
Herlev Hospital Recruiting
Herlev, Capital Region, Denmark, 2730
Contact: Jacob H Grauslund, MD         
National Center for Cancer Immune Therapy (CCIT-DK) Recruiting
Herlev, Denmark, 2730
Contact: Jacob H Grauslund, MD    +4538688961    jgra0033@regionh.dk   
Sponsors and Collaborators
Inge Marie Svane
Investigators
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Principal Investigator: Jacob H Grauslund, MD CENTER FOR CANCER IMMUNE THERAPY, CCIT-DK

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Responsible Party: Inge Marie Svane, Prof, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT04051307     History of Changes
Other Study ID Numbers: MPN19H2
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Polycythemia Vera
Polycythemia
Myeloproliferative Disorders
Thrombocytosis
Thrombocythemia, Essential
Neoplasms
Hematologic Diseases
Bone Marrow Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Vaccines
Immunologic Factors
Physiological Effects of Drugs