Dual Vaccine Trial in Myeloproliferative Neoplasms
- Conditions
- Myeloproliferative NeoplasmsMedDRA version: 20.1Level: LLTClassification code 10028576Term: Myeloproliferative disorderSystem Organ Class: 100000004864MedDRA version: 20.1Level: LLTClassification code 10036061Term: Polycythemia veraSystem Organ Class: 100000004864MedDRA version: 20.1Level: LLTClassification code 10015494Term: Essential thrombocythemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001434-34-DK
- Lead Sponsor
- Department of haematology, Zealand university hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
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 < 2.5 upper normal limit, i.e. < 300 µmol/l
7.Sufficient liver function, i.e.
a.ALAT < 2.5 upper normal limit, i.e. ALAT <112 U/l
b.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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