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Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients (ScIGalloHCT)

Primary Purpose

Hypogammaglobulinemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
subcutaneous immunoglobulin
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogammaglobulinemia focused on measuring hypogammaglobulinemia, allogeneic hematopoietic cell transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

Tolerability of home ScIG as replacement therapy for hypogammaglobulinemia in allogeneic transplant patients
Qualitative survey describing tolerability, QOL assessment

Secondary Outcome Measures

Financial analysis of cost of ScIG in allogeneic HCT patients
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.

Full Information

First Posted
January 5, 2018
Last Updated
May 7, 2019
Sponsor
University Health Network, Toronto
Collaborators
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT03401268
Brief Title
Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients
Acronym
ScIGalloHCT
Official Title
A Pilot Study to Assess Tolerability of Subcutaneous Immunoglobulin Treatment (Hizentra) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
CSL Behring

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogammaglobulinemia
Keywords
hypogammaglobulinemia, allogeneic hematopoietic cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
subcutaneous immunoglobulin
Other Intervention Name(s)
ScIG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tolerability of home ScIG as replacement therapy for hypogammaglobulinemia in allogeneic transplant patients
Description
Qualitative survey describing tolerability, QOL assessment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Financial analysis of cost of ScIG in allogeneic HCT patients
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fotios V. Michelis, MD, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33684377
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.
Results Reference
derived

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Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients

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