NCT04051307已完成1 期
Dual Vaccine Trial in Myeloproliferative Neoplasms
Inge Marie Svane3 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年7月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Immune response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of essential thrombocythemia or Polycythemia Vera, according to the WHO criteria123,124
- •Age ≥18 years
- •Performance status ≤ 2 (ECOG-scale)
- •Expected survival > 3 months
- •Sufficient bone marrow function
- •Creatinine < 2.5 upper normal limit, i.e. < 300 µmol/l
- •Sufficient liver function, i.e.
- •ALAT < 2.5 upper normal limit, i.e. ALAT <112 U/l
- •Bilirubin < 30 U/l
- •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.
排除标准
- 未提供
结局指标
主要结局
Immune response
时间窗: 1 year
T-cell cytokine release towards target antigens
次要结局
- Adverse events evaluated by CTCAE v. 5.0(1 year)
- Clinical response(10 year)
研究者
Inge Marie Svane
Prof, MD
Herlev Hospital
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
1 期
Dual Vaccine Trial in Myeloproliferative NeoplasmsMyeloproliferative 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: 100000004864EUCTR2019-001434-34-DKDepartment of haematology, Zealand university hospital48
已完成
1 期
Safety of Peptide Vaccination for Patients With Myelodysplastic SyndromeMyelodysplastic Syndrome (MDS)NCT00270452National Heart, Lung, and Blood Institute (NHLBI)9
已完成
1 期
Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia MyelofibrosisPost-Polycythemia VeraPost-Essential Thrombocythemia MyelofibrosisPrimary MyelofibrosisNCT01423058Sierra Oncology LLC - a GSK company61
已完成
1 期
Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular LymphomaFollicular LymphomaNCT03381768Lars Møller Pedersen8
已完成
1 期
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid HemopathyChronic Myeloid LeukemiaMyelodysplastic SyndromeAcute Myeloid LeukemiaNCT01819558Institut Paoli-Calmettes2