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Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

Primary Purpose

Secondary Immune Deficiency

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
20% subcutaneous immunoglobulin
Sponsored by
Rochester General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Immune Deficiency focused on measuring Rituximab, Non Hodgkin's Lymphoma, Subcutaneous Immunoglobulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allergy and Immunology, 222 Alexander Street

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immunoglobulin therapy

Arm Description

Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin.

Outcomes

Primary Outcome Measures

Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment
How many antibiotics are prescribed in one year for any type of infection

Secondary Outcome Measures

Quality of life score for participants during the one year enrollment
Assessed with Short Form 36 (SF 36)

Full Information

First Posted
July 3, 2017
Last Updated
April 14, 2021
Sponsor
Rochester General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03211065
Brief Title
Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 21, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rochester General Hospital

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Immune Deficiency
Keywords
Rituximab, Non Hodgkin's Lymphoma, Subcutaneous Immunoglobulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immunoglobulin therapy
Arm Type
Experimental
Arm Description
Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin.
Intervention Type
Drug
Intervention Name(s)
20% subcutaneous immunoglobulin
Other Intervention Name(s)
Cuvitru
Intervention Description
Subcutaneous Immunoglobulin
Primary Outcome Measure Information:
Title
Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment
Description
How many antibiotics are prescribed in one year for any type of infection
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life score for participants during the one year enrollment
Description
Assessed with Short Form 36 (SF 36)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of B cell non-Hodgkin's lymphoma Medically stable 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 Ongoing therapy with Ig replacement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Shahzad Mustafa, MD
Organizational Affiliation
Rochester Regional Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy and Immunology, 222 Alexander Street
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

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