EUCTR2020-002017-18-FR进行中（未招募）1 期
Clinical trial assessing the immunogenicity of an anti-pneumococcal combined vaccination strategy in adult patients treated for an acute leukemia or a lymphoma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patient = 18 year-old.
- •- AND medical follow-up in hematology unit
- •- AND had received a first course of chemotherapy for acute myeloblastic leukemia without PML-RARa and no planned allogeneic hematopoietic stem cell transplantation or for diffuse large B cell lymphoma or for follicular lymphoma
- •- Life expectancy > 6 months
- •- Having signed the consent form.
- •- Having an health insurance.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Receiving monoclonal antibodies or biotherapies altering the immune response, other than anti-CD20 antibodies in the chemotherapy protocol.
- •- Previous vaccination with PCV13 or PPV23 (unless PCV13 was administered in childhood. The last injection must be performed at least five years ago).
- •- Preexisting condition that altered the immune response: splenectomy, HIV, primary or secondary immune deficiency, nephrotic syndrome, sickle cell anemia, autoimmune disorder, solid organ transplantation, immunosuppressive drugs or biotherapy not included in the chemotherapy.
- •- Patient who already received chemotherapy for malignancy in the previous 2 years before the inclusion.
- •- Allogeneic hematopoietic stem cell transplantation planned in the following 3 months after the first chemotherapy course.
- •- Curative anticoagulation within 7 days before vaccination.
- •- Major blood clotting disorders preventing intramuscular injection.
- •- Medical history of anaphylactic reaction to vaccination.
- •- Known allergy to one of the vaccine components.
- •- Involvement to another vaccine biomedical research.
- •- Protected person.
- •- Pregnant women or women of childbearing age without appropriate contraceptive measures.
- •- Perfusion of polyvalent immunoglobulins during follow-up.
研究者
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