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临床试验/NCT03730129
NCT03730129已完成2 期

A Prospective Case Series of Subcutaneous Immunoglobulin for Prophylaxis of Infections in Patients With Chronic Lymphocytic Leukemia With Impaired Humoral Immunity

Rochester General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年11月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Identify patients with CLL with humoral immunodeficiency despite serum IgG > 500 mg/dL.

研究概览

简要总结

Patients with chronic lymphocytic leukemia (CLL) are at increased risk of infections as compared to age matched controls, with infections being a major cause of morbidity and mortality. Previous studies have shown that patients with CLL have both hypogammaglobinemia and impaired humoral immunity as defined by vaccine responses to both polysaccharide and peptide antigens. Attempts at decreasing infections in CLL have included therapy with prophylactic antibiotics and intravenous immunoglobulin. In general clinical practice and in previous studies, patients have started IV immunoglobulin replacement therapy if they have a history of serious infection or hypogammaglobinemia (defined as Immunoglobulin G below 500-600 g/dL), but vaccine responses have not been evaluated. This study will identify CLL patients with humoral immunodeficiency by checking both Ig levels and vaccines responses. In patients with impaired humoral immunity, the investigators will use subcutaneous immunoglobulin replacement to show this intervention will increase Ig levels, protective antibody titers, and be well tolerated.

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

入选标准

  • Diagnosis of chronic lymphocytic leukemia
  • Medically stable, with expected survival of > 1 year
  • Able to understand and willingness to sign a written informed consent
  • Able to comply with study procedures

排除标准

  • Previously diagnosed primary immunodeficiency
  • Additional immunosuppressive states as assessed by the primary or co investigators
  • Ongoing therapy with Ig replacement
  • Serum IgG < 500 mg/dL

研究组 & 干预措施

Ig replacement

Experimental

Subjects will receive Hizentra 0.4 mg/kg subq once weekly.

干预措施: Hizentra (Drug)

结局指标

主要结局

Identify patients with CLL with humoral immunodeficiency despite serum IgG > 500 mg/dL.

时间窗: 10 months

Incidence of humoral immunodeficiency

Number of patients who increase IgG to above 700 mg/dL

时间窗: 10 months

Effectiveness of Hizentra to change IgG levels

次要结局

  • Number of subjects with treatment-related adverse effects as assessed by CTCAE v4.0(10 months)
  • Quality of life (Short Form 36) on subcutaneous Ig replacement therapy a 0-100 scale, with lower scores indicating higher disability/lower quality of life(10 months)
  • Track the number of infections requiring antibiotics, further characterized per severity as defined in previous studies(10 months)
  • Number of patients who increase diphtheria IgG to above 0.1 IU/mL, tetanus IgG to above 0.1 IU/mL, and IgG to streptococcus pneumonia to above 1.3 mcg/mL(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

S. Shahzad Mustafa

Associate Medical Director

Rochester General Hospital

研究点 (1)

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