CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
Hizentradrug
Likely dose
Hizentra 0.4 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03730129
NCT03730129Phase 3Completed

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

Rochester General Hospital·interventional·Posted Nov 5, 2018·Updated Aug 26, 2020

In Brief

A Phase 3 clinical trial evaluating Hizentra for Secondary Immune Deficiency Disorder. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 5, 2018
Enrollment StartNov 5, 2018
Primary CompletionJul 3, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.7 years ago

Interventions

Hizentradrug

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