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ScIGalloHCT: Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT03401268
Collaborator
CSL Behring (Industry)
20
Enrollment
1
Location
1
Arm
14.9
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: subcutaneous immunoglobulin
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study to Assess Tolerability of Subcutaneous Immunoglobulin Treatment (Hizentra) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient cohort

The study population will include 24 patients, that are either already on IVIG or are eligible for ScIG as initial Ig replacement, that will undergo Ig replacement with subcutaneous immunoglobulin (ScIG) for a total of 6 months.

Drug: subcutaneous immunoglobulin
24 patients demonstrating hypogammaglobulinemia post allogeneic HCT will be started on ScIG for a total of 6 months. Tolerability of the intervention will be assessed with qualitative questionnaires, as well as a financial analysis regarding the intervention.
Other Names:
  • ScIG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tolerability of home ScIG as replacement therapy for hypogammaglobulinemia in allogeneic transplant patients [6 months]

      Qualitative survey describing tolerability, QOL assessment

    Secondary Outcome Measures

    1. Financial analysis of cost of ScIG in allogeneic HCT patients [1 year]

      A cost comparison will be performed between the ScIG population and a retrospectively assessed population of allogeneic HCT patients that received IVIG. This will be assessed by a financial analysis and retrospective chart review.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto
    • CSL Behring

    Investigators

    • Principal Investigator: Fotios V. Michelis, MD, PhD, University Health Network, Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT03401268
    Other Study ID Numbers:
    • ScIG alloHCT
    First Posted:
    Jan 17, 2018
    Last Update Posted:
    May 9, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University Health Network, Toronto
    hypogammaglobulinemia
    allogeneic hematopoietic cell transplantation
    Additional relevant MeSH terms:
    Agammaglobulinemia
    Immunoglobulins
    Immunoglobulins, Intravenous
    Antibodies

    Study Results

    No Results Posted as of May 9, 2019