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临床试验/ACTRN12617001008314
ACTRN12617001008314终止4 期

An Australian multicentre prospective randomised study to compare the safety and efficacy of intravenous immunoglobulin replacement therapy with subcutaneous immunoglobulin replacement therapy (Hizentra®) to treat acquired hypogammaglobulinaemia in patients with chronic lymphocytic leukaemia (CLL)

Professor Stephen Mulligan0 个研究点目标入组 15 人开始时间: 2017年7月12日最近更新:
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试验速览

阶段
4 期
状态
终止
发起方
入组人数
15
研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit（—）
性别
All

入选标准

  • •1.Diagnosis of chronic lymphocytic leukaemia (CLL) according to NCI/IWCLL criteria
  • •2.IgG < 6.5 g/L prior to commencement of IVIg
  • •3.Recurrent episodes of non-neutropenic bacterial infection (>2 infections per year requiring antibiotics, or severe non-neutropenic bacterial infection (requiring hospitalisation and IV antibiotics
  • •4.Currently receiving, and stable on IVIg as per the National Blood Authority, State Australian Red Cross Blood Transfusion Service, and local institutional approved guidelines for the provision of IVIg, or patients requiring commencement of immunoglobulin replacement therapy according to standard guidelines
  • •5.An ECOG performance status score of 0-2 at Screening
  • •6.Able to comply with study protocol procedures and a minimum of 1 month of follow-up
  • •7.Able to provide written informed consent
  • •8.Adequate level of physical and mental capacity to allow self-administration of SCIg following a training period
  • •9.Ability to adhere to a self-administration treatment plan
  • •10.Life expectancy of at least 12 months

排除标准

  • •1.Patients with CLL who are not hypogammaglobulinaemic and hence ineligible for immunoglobulin replacement under Australian National Blood Authority Guidelines.
  • •2.Transformation of CLL to aggressive NHL (Richter’s transformation)
  • •3.Ongoing requirement for treatment with high dose corticosteroids at a dose equivalent to or greater than 30 mg/day prednisolone
  • •4.Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying leukaemia):
  • •a.AST or ALT greater than or equal to 2.5 × ULN
  • •b.Total bilirubin greater than or equal to 3 × ULN
  • •5.One or more individual organ / system impairment score(s) of 4 as assessed by the CIRS definition (i.e. extremely severe problem and/or immediate treatment required and/or organ failure and/or severe functional impairment)
  • •6.Prior diagnosis of malignancy, unless:
  • •a.the malignancy has been treated with a curative intent and there is no evidence of recurrence or
  • •b.in remission without treatment for greater than or equal to 2 years prior to study enrolment
  • •7.Previous severe adverse reaction to IVIg requiring inpatient monitoring
  • •8.Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, severe arrhythmia, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
  • •9.Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalisation (relating to the completion of the course of antibiotics, except if for tumour fever) within 4 weeks prior to the start of Cycle 1
  • •10.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.

研究者

发起方
Professor Stephen Mulligan

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