Clinical trial NCT05612607: Switched Memory B-cells as a Marker for Humoral Immune System Recovery in Patients With Secondary Antibody Deficiency Due to Hematological Malignancies
Official title: Switched Memory B-cells as a Marker for Humoral Immune System Recovery in Patients With Secondary Antibody Deficiency Due to Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Secondary Antibody Deficiency
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: IGRT discontinuation sucess rate
timeFrame: 12 months post discontinuation
measure: IGRT discontinuation rate
timeFrame: 12 months post discontinuation
Secondary outcomes:
measure: Change in Health-Related Quality of Life
timeFrame: Through study completion, an average of 1 year
measure: Change in Health-Related Quality of Life
timeFrame: Through study completion, an average of 1 year
measure: Cost saving potential
timeFrame: Through study completion, an average of 1 year
measure: Receiver operating curve (ROC)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
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