Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

April 14, 2021 updated by: S. Shahzad Mustafa, Rochester General Hospital

The Use of 20% Subcutaneous Immunoglobulin Replacement Therapy in Patients With B Cell Non Hodgkin's Lymphoma With Humoral Immune Dysfunction After Treatment With Rituximab

To study the use of subcutaneous (injected under the skin) immunoglobulin replacement therapy (replacement of antibodies, which are infection-fighting proteins) in patients with a type of blood cancer called lymphoma, who have been treated with rituximab (a type of chemotherapy) and have an abnormal immune system putting them at increased risk of infection.

Study Overview

Status

Completed

Detailed Description

The investigators propose evaluating patients with B cell non-Hodgkin's lymphoma treated with rituximab within the past 2 years with baseline immunoglobulin levels and vaccine responses to polysaccharide (pneumococcus, meningococcus) and peptide (tetanus, diphtheria) antigens. Patients with impaired vaccine responses may benefit most from immunoglobulin prophylaxis and will be proactively started on 20% subcutaneous replacement therapy. This study is novel in that it will stratify patients according to their humoral response to polysaccharide and peptide vaccines, and will proactively initiate therapy with the new 20% subcutaneous immunoglobulin in those with impaired humoral response rather than starting it after infections occur. This will potentially lead to decreased infections and improved quality of life.

Study Type

Interventional

Enrollment (Actual)

16

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

    • New York
      • Rochester, New York, United States, 14607
        • Allergy and Immunology, 222 Alexander Street

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:

  1. Diagnosis of B cell non-Hodgkin's lymphoma
  2. Medically stable
  3. Able to understand and willingness to sign a written informed consent
  4. Able to comply with study procedures

Exclusion Criteria:

  1. Previously diagnosed primary immunodeficiency
  2. Additional immunosuppressive states
  3. Ongoing therapy with Ig replacement

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: Immunoglobulin therapy
Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin.
Subcutaneous Immunoglobulin
Other Names:
  • Cuvitru

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment
Time Frame: 1 year
How many antibiotics are prescribed in one year for any type of infection
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score for participants during the one year enrollment
Time Frame: 1 year
Assessed with Short Form 36 (SF 36)
1 year

Collaborators and Investigators

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

Investigators

  • Principal Investigator: S Shahzad Mustafa, MD, Rochester Regional Health

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)

July 21, 2017

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

November 1, 2019

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

July 5, 2017

First Posted (ACTUAL)

July 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

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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