Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig

Phase 2

Completed

• Conditions: Secondary Immune Deficiency Disorder
• Interventions: Drug: Hizentra

• Registration Number: NCT03730129
• Lead Sponsor: Rochester General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-11-01
• Study Start: 2018-11-05
• Study First Posted: 2018-11-05
• Primary Completion: 2020-07-03
• Study Completion: 2020-07-03
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ig replacement	Hizentra	Subjects will receive Hizentra 0.4 mg/kg subq once weekly.

Primary Outcome Measures

Name	Time	Method
Identify patients with CLL with humoral immunodeficiency despite serum IgG > 500 mg/dL.	10 months	Incidence of humoral immunodeficiency
Number of patients who increase IgG to above 700 mg/dL	10 months	Effectiveness of Hizentra to change IgG levels

Secondary Outcome Measures

Name	Time	Method
Number of subjects with treatment-related adverse effects as assessed by CTCAE v4.0	10 months	Safety and tolerability of Hizentra in CLL
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	Does Hizentra change quality of life scores in patients with CLL
Track the number of infections requiring antibiotics, further characterized per severity as defined in previous studies	10 months	Does Hizentra change the rate of non-neutropenic infections in CLL
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	Effectiveness of Hizentra to change specific antibody titers in CLL

Trial Locations

Locations (1)

Allergy, Immunology, Rheumatology at Rochester Regional Health; 🇺🇸 Rochester, New York, United States