Clinical trial NCT03730129: Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig
Official title: A Prospective Case Series of Subcutaneous Immunoglobulin for Prophylaxis of Infections in Patients With Chronic Lymphocytic Leukemia With Impaired Humoral Immunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Secondary Immune Deficiency Disorder
Keywords: chronic lymphocytic leukemia
Lead sponsor: Rochester General Hospital
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Identify patients with CLL with humoral immunodeficiency despite serum IgG > 500 mg/dL.
timeFrame: 10 months
measure: Number of patients who increase IgG to above 700 mg/dL
timeFrame: 10 months
Secondary outcomes:
measure: 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
timeFrame: 10 months
measure: Number of subjects with treatment-related adverse effects as assessed by CTCAE v4.0
timeFrame: 10 months
measure: 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
timeFrame: 10 months
measure: Track the number of infections requiring antibiotics, further characterized per severity as defined in previous studies
timeFrame: 10 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Allergy, Immunology, Rheumatology at Rochester Regional Health
state: New York
Study officials:
affiliation: Rochester General Hospital
name: Shahzad Mustafa, MD
role: PRINCIPAL_INVESTIGATOR
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