Secondary Antibody DeficiencyPhase 4SADNCT05612607
Switched Memory B-cells as a Marker for Humoral Immune System Recovery in Patients With Secondary Antibody Deficiency Due to Hematological Malignancies
A Phase 4 study testing Immunoglobulin replacement therapy (IGRT) in people with Secondary Antibody Deficiency, run by Ottawa Hospital Research Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Antibody Deficiency
- What is being tested?
- Immunoglobulin replacement therapy (IGRT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2022to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of leukemia, lymphoma, or plasma cell disease
- Receiving IGRT for SAD for at least 12 months
- Over 18 years of age
- Able to provide informed consent
- Able to speak English or French
- Available for ongoing follow-up as required
Who cannot join
- Receiving chemotherapy or immune-oncology treatment during the study period
- Severe infection within the last 6 months
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Secondary Antibody Deficiency
- Being tested
- Immunoglobulin replacement therapy (IGRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin replacement therapy (IGRT)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| IGRT discontinuation | Other | 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. Receives: Drug: Immunoglobulin replacement therapy (IGRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGRT discontinuation sucess rate
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.
Measured: 12 months post discontinuation
IGRT discontinuation rate
IGRT discontinuation rate defined as the proportion of recruited adult patients with SAD who discontinue IGRT during the study period.
Measured: 12 months post discontinuation
Secondary outcomes (4)
Change in Health-Related Quality of Life
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.
Measured: Through study completion, an average of 1 year
Change in Health-Related Quality of Life
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.
Measured: Through study completion, an average of 1 year
Cost saving potential
Calculated potential cost saving based on the study IGRT discontinuation rate using SMB as a marker for discontinuation.
Measured: Through study completion, an average of 1 year
Receiver operating curve (ROC)
We will estimate a receiver operating curve (ROC) of SMB proportion as a predictor of successful discontinuation.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start10 Nov 2022 (estimated)
- Primary completion10 Oct 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Antibody DeficiencyStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will be tested to determine SMB cell proportion/SMB cell levels for eligibility for IGRT discontinuation. 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612607
- Sponsor's protocol ID
- 20220516-01H
- Acronym
- SAD
- Status last verified
- Nov 2022
- First submitted
- 1 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switched Memory B-cells as a Marker for Humoral Immune System Recovery in Patients With Secondary Antibody Deficiency Due to Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05612607
- Acronym / sponsor ID
- SAD / 20220516-01H
- Conditions
- Secondary Antibody Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 10 Nov 2022 (estimated)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be tested to determine SMB cell proportion/SMB cell levels for eligibility for IGRT discontinuation. 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.
| Arm | Type | Receives |
|---|---|---|
| IGRT discontinuation | Other | Drug: Immunoglobulin replacement therapy (IGRT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of leukemia, lymphoma, or plasma cell disease
- Receiving IGRT for SAD for at least 12 months
- Over 18 years of age
- Able to provide informed consent
- Able to speak English or French
Key exclusion criteria (3 listed)
- Receiving chemotherapy or immune-oncology treatment during the study period
- Severe infection within the last 6 months
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | IGRT discontinuation |
Primary outcome
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.
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.
4 secondary outcomes
Change in Health-Related Quality of Life
Time frame: 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
Cost saving potential
Time frame: Through study completion, an average of 1 year
Receiver operating curve (ROC)
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immunoglobulin replacement therapy (IGRT) in people with Secondary Antibody Deficiency, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juthaporn Cowan, MD, PhD, FRCPC, FAPC (6137378899 ext. 79617, jcowan@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGRT discontinuation sucess rate (time frame: 12 months post discontinuation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.