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

Ottawa Hospital Research Institute

Status and phase: Not yet enrolling; Phase 4

Conditions: Secondary Antibody Deficiency

Treatments: Drug: Immunoglobulin replacement therapy (IGRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05612607

20220516-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

IGRT discontinuation

Other group

Description:

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.

Treatment:

Drug: Immunoglobulin replacement therapy (IGRT)