Clinical trial NCT03401268: Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients
Official title: A Pilot Study to Assess Tolerability of Subcutaneous Immunoglobulin Treatment (Hizentra) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypogammaglobulinemia
Keywords: hypogammaglobulinemia
allogeneic hematopoietic cell transplantation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2018-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tolerability of home subcutaneous immunoglobulin (ScIG) for replacement therapy for hypogammaglobulinemia in allogeneic HCT patients. A financial analysis comparing the cost of ScIG with intravenous immunoglobulin (IVIG) will also be performed.

Detailed description: The purpose of the study is to determine whether home subcutaneous immunoglobulin (ScIG) is tolerated as replacement therapy for hypogammaglobulinemia in patients that have undergone allogeneic hematopoietic cell transplantation (alloHCT). Secondary objective is to perform a financial analysis comparing the cost of ScIG with intravenous immunoglobulin (IVIG). The study hypothesis is that home based SCIG treatment is applicable and tolerated well for replacement treatment in alloHCT patients. This will be examined in two sets of patients recruited: A) Patients already on IVIG replacement therapy and B) Newly diagnosed patients with hypogammaglobulinemia. Economic analysis will be performed by comparing the cost with an equal number of patients retrospectively determined to have undergone treatment with IVIG.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Patients at least 100 days post allogeneic hematopoietic cell transplantation for any benign or malignant hematological disease, from a related or unrelated donor
* Patients who are already established on regular IVIG
* Patients eligible for immunoglobulin replacement with an IgG \<7mg/L, or normal IgG total but IgG2 or IgG4 below normal
* Patients with IgG =\>7g/L but with at least 2 prior episodes of bacterial infection (proven or suspected eg. sinusitis diagnosed on CT)
* No other medical condition which would preclude treatment with immunoglobulin
* Willing to participate and sign informed consent

Exclusion Criteria:

* Previous serious adverse reaction from IVIG or products from Hizentra (polysorbate)
* Other serious medical or psychiatric disorders which may interfere with the patient's ability to participate in the study, or interfere with study assessment (e.g. advanced congestive heart failure, severe liver disease, renal failure, disease relapse or secondary malignancy, schizophrenia, paranoid psychosis)

Primary outcomes:
measure: Tolerability of home ScIG as replacement therapy for hypogammaglobulinemia in allogeneic transplant patients
timeFrame: 6 months
Secondary outcomes:
measure: Financial analysis of cost of ScIG in allogeneic HCT patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Fotios V. Michelis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pasic I, Alanazi W, Dranitsaris G, Lieberman L, Viswabandya A, Kim DDH, Lipton JH, Michelis FV. Subcutaneous immunoglobulin in allogeneic hematopoietic cell transplant patients: A prospective study of feasibility, safety, and healthcare resource use. Hematol Oncol Stem Cell Ther. 2021 Dec;14(4):302-310. doi: 10.1016/j.hemonc.2021.01.001. Epub 2021 Feb 23.