Switched Memory B-cells as a Marker for Humoral Immune System Recovery in Patients With Secondary Antibody Deficiency Due to Hematological Malignancies (SAD)

November 4, 2022 updated by: Ottawa Hospital Research Institute
Current treatment for patients with secondary antibody deficiency (SAD) is Immunoglobulin replacement therapy (IGRT). There are currently no clinical guidelines for IGRT discontinuation in patients with SAD. This study will examine the IGRT discontinuation success rate and IGRT discontinuation rate in patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Immunoglobulin replacement therapy (IGRT) is a mainstay treatment for SAD and has been shown to reduce the risk of infection and increase quality of life in patients with SAD. Current guidelines recommend that patients with severe hypogammaglobulinemia (IgG <4 g/L) or patients with a history of recurrent or severe infections should be offered IGRT, which can be administered intravenously on a monthly basis or more frequently by subcutaneous infusions. There are currently no clinical guidelines for IGRT discontinuation. Although research conducted at the Ottawa Hospital indicates successful discontinuation of IGRT, clinicians need a tool to predict the recovery of humoral immunity and the risk of infection in these patients in order to determine whether IGRT may be safely discontinued.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

  • Name: Juthaporn Cowan, MD, PhD, FRCPC, FAPC
  • Phone Number: 79617 6137378899
  • Email: jcowan@toh.ca

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. History of leukemia, lymphoma, or plasma cell disease
  2. Receiving IGRT for SAD for at least 12 months
  3. Over 18 years of age
  4. Able to provide informed consent
  5. Able to speak English or French
  6. Available for ongoing follow-up as required

Exclusion Criteria:

  1. Receiving chemotherapy or immune-oncology treatment during the study period
  2. Severe infection within the last 6 months
  3. Pregnancy

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: IGRT discontinuation
Participants will be tested to determine Switched memory B cells (SMB) levels. If SMB cells are ≥ 2%, IGRT will be discontinued. If SMB cells are < 2%, the patient will remain on IGRT and a maximum of 40 mL of blood will be drawn again in 3-6 months to reassess SMB levels and eligibility for IGRT discontinuation.
Drug: Immunoglobulin replacement therapy (IGRT)
IGRT discontinuation will be dependent on participant's SMB levels. If SMB cells are ≥ 2%, IGRT will be discontinued. If SMB cells are < 2%, the patient will remain on IGRT and a maximum of 40 mL of blood will be drawn again in 3-6 months to reassess SMB levels and eligibility for IGRT discontinuation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IGRT discontinuation sucess rate
Time Frame: 12 months post discontinuation
IGRT discontinuation success rate defined as the proportion of patients with normal SMB levels who stop IGRT and experience less than or equal to 1 moderate infection and no severe infection within 12 months of IGRT discontinuation. Moderate infection will be defined as an infection that requires outpatient oral antimicrobial treatment. Severe infection will be defined as an infection that requires intravenous antimicrobial treatment and/or hospitalization.
12 months post discontinuation
IGRT discontinuation rate
Time Frame: 12 months post discontinuation
IGRT discontinuation rate defined as the proportion of recruited adult patients with SAD who discontinue IGRT during the study period.
12 months post discontinuation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health-Related Quality of Life
Time Frame: Through study completion, an average of 1 year
Change in Health-Related Quality of Life (HRQoL) before and after IGRT discontinuation. The 36-item Short Form Survey (SF-36, RAND Corporation) will be used to obtain HRQoL data.
Through study completion, an average of 1 year
Change in Health-Related Quality of Life
Time Frame: Through study completion, an average of 1 year
Change in Health-Related Quality of Life (HRQoL) before and after IGRT discontinuation. The Euroqol 5-dimension 5-level (EQ-5D-5L) questionnaire will be used to obtain HRQoL data.
Through study completion, an average of 1 year
Cost saving potential
Time Frame: Through study completion, an average of 1 year
Calculated potential cost saving based on the study IGRT discontinuation rate using SMB as a marker for discontinuation.
Through study completion, an average of 1 year
Receiver operating curve (ROC)
Time Frame: Through study completion, an average of 1 year
We will estimate a receiver operating curve (ROC) of SMB proportion as a predictor of successful discontinuation.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Ottawa Hospital Research Institute

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 (Anticipated)

November 10, 2022

Primary Completion (Anticipated)

October 10, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

October 1, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220516-01H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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