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Trial Title:
Switched Memory B-cells as a Marker for Humoral Immune System Recovery in Patients With Secondary Antibody Deficiency Due to Hematological Malignancies
NCT ID:
NCT05612607
Condition:
Secondary Antibody Deficiency
Conditions: Official terms:
Neoplasm Metastasis
Hematologic Neoplasms
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Immunoglobulin replacement therapy (IGRT)
Description:
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.
Arm group label:
IGRT discontinuation
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 10, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ottawa Hospital Research Institute
Agency class:
Other
Source:
Ottawa Hospital Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05612607
