Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig

August 25, 2020 updated by: S. Shahzad Mustafa, Rochester General Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14607
        • Allergy, Immunology, Rheumatology at Rochester Regional Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ig replacement
Subjects will receive Hizentra 0.4 mg/kg subq once weekly.
Drug: Hizentra
Subjects will receive Hizentra 0.4 mg/kg qweekly subcutaneously for 6 months (24 weeks)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 months
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
10 months
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
10 months
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
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rochester General Hospital

Investigators

  • Principal Investigator: Shahzad Mustafa, MD, Rochester General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 5, 2018

Primary Completion (ACTUAL)

July 3, 2020

Study Completion (ACTUAL)

July 3, 2020

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

November 1, 2018

First Posted (ACTUAL)

November 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIC1850-A-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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