Dual Vaccine Trial in Myeloproliferative Neoplasms

Department of haematology, Zealand university hospital0 个研究点目标入组 48 人开始时间: 2019年4月24日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•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.

发起方

Department of haematology, Zealand university hospital