Back to resultsContinuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD (CARE)
Primary Purpose
Chronic GVHD After HCT for Cancer or Immune Disease
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte.
Sponsored by
About this trial
This is an interventional basic science trial for Chronic GVHD After HCT for Cancer or Immune Disease focused on measuring post stem cell transplantation, Steroid refractory, dependent chronic
Eligibility Criteria
Inclusion Criteria: (Main)
- 1. Newly diagnosed chronic GVHD as defined by the National Institutes of Health (NIH) Consensus with no more than 24 weeks of treatment with systemic steroids.
AND 2. Chronic GVHD must be refractory or dependent to standard therapy, defined as (one of the following):
- Progression on prednisone 7 mg/kg/week for 2 weeks, or
- Stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or
- Inability to taper prednisone below 3.5 mg/kg/week.
Exclusion Criteria: (Main)
- 1. Persistent, recurrent or late-onset acute GVHD, without signs of chronic GVHD.
OR 2. Overlap GVHD syndrome with uncontrolled features of previously diagnosed acute GVHD.
OR 3. Treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks prior to enrollment.
OR 4. Time from allogeneic transplantation > 2 years. OR 5. Lymphocyte count < 0.2 x 109/L on two last consecutive CBCs before inclusion
Sites / Locations
- Hospital Maissoneuve
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Open-label phase II study. After signing informed consent, patients will undergo 6 times an apheresis during the 6-month treatment period. These cells will be manufactured into the Rhitol and frozen in aliquots. Then re-infused.
Outcomes
Primary Outcome Measures
The primary endpoint is failure-free survival (FFS) at 24 weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02519816
Brief Title
Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD
Acronym
CARE
Official Title
Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
daphne brockington
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with steroid-refractory or dependent chronic graft vs host disease.
Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks. Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell depletion and Regulatory T-cell Expansion)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic GVHD After HCT for Cancer or Immune Disease
Keywords
post stem cell transplantation, Steroid refractory, dependent chronic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Open-label phase II study. After signing informed consent, patients will undergo 6 times an apheresis during the 6-month treatment period. These cells will be manufactured into the Rhitol and frozen in aliquots. Then re-infused.
Intervention Type
Other
Intervention Name(s)
Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte.
Primary Outcome Measure Information:
Title
The primary endpoint is failure-free survival (FFS) at 24 weeks
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (Main)
1. Newly diagnosed chronic GVHD as defined by the National Institutes of Health (NIH) Consensus with no more than 24 weeks of treatment with systemic steroids.
AND 2. Chronic GVHD must be refractory or dependent to standard therapy, defined as (one of the following):
Progression on prednisone 7 mg/kg/week for 2 weeks, or
Stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or
Inability to taper prednisone below 3.5 mg/kg/week.
Exclusion Criteria: (Main)
1. Persistent, recurrent or late-onset acute GVHD, without signs of chronic GVHD.
OR 2. Overlap GVHD syndrome with uncontrolled features of previously diagnosed acute GVHD.
OR 3. Treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks prior to enrollment.
OR 4. Time from allogeneic transplantation > 2 years. OR 5. Lymphocyte count < 0.2 x 109/L on two last consecutive CBCs before inclusion
Facility Information:
Facility Name
Hospital Maissoneuve
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD
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