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OpenTrials
Completed

NCT Number: NCT03730129

Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Hizentra

Drug

Subjects will receive Hizentra 0.4 mg/kg qweekly subcutaneously for 6 months (24 weeks)

Primary outcomes

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

    Time frame: 10 months

    Incidence of humoral immunodeficiency

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

    Time frame: 10 months

    Effectiveness of Hizentra to change IgG levels

Secondary outcomes

  1. 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

    Time frame: 10 months

    Effectiveness of Hizentra to change specific antibody titers in CLL

  2. Number of subjects with treatment-related adverse effects as assessed by CTCAE v4.0

    Time frame: 10 months

    Safety and tolerability of Hizentra in CLL

  3. 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

    Time frame: 10 months

    Does Hizentra change quality of life scores in patients with CLL

  4. Track the number of infections requiring antibiotics, further characterized per severity as defined in previous studies

    Time frame: 10 months

    Does Hizentra change the rate of non-neutropenic infections in CLL

Sponsors and collaborators

Lead sponsor

Rochester General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2018
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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