Dual Vaccine Trial in Myeloproliferative Neoplasms

Polycythemia Vera Clinical Trial

Official title:

Dual Vaccine Trial in Myeloproliferative Neoplasms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051307
• Other study ID #: MPN19H2
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 10, 2019
• Est. completion date: July 10, 2022

Study information

• Verified date: July 2023
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 10, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Myeloproliferative Disorders
• Neoplasms
• Polycythemia
• Polycythemia Vera
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Drug:
• PD-L1 peptide: PD-L1 Long(19-27) Peptide sequence: FMTYWHLLNAFTVTVPKDL
Peptide vaccination
• Arginase1 peptide: ArgLong2(169-206) Peptide sequence ISAKDIVYIGLRDVDPGEHYILKTLGIKYFSMTEVDRL
Peptide vaccination

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev	Capital Region
Denmark	National Center for Cancer Immune Therapy (CCIT-DK)	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Inge Marie Svane

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response	T-cell cytokine release towards target antigens	1 year
Secondary	Adverse events evaluated by CTCAE v. 5.0	Adverse events are graded 1-5 according to the criteria	1 year
Secondary	Clinical response	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.	10 year