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Intervention for Graft-versus-Host Disease (CARE Trial)
Phase 2
Waitlist Available
Research Sponsored by daphne brockington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
CARE Trial 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)
Eligible Conditions
- Graft-versus-Host Disease
CARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary endpoint is failure-free survival (FFS) at 24 weeks
Side effects data
From 2016 Phase 4 trial • 40 Patients • NCT0213514615%
Pulmonary Edema
5%
Atrial Fibrillation
5%
Supraventricular tachycardia (SVT)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Plasmalyte 6ml/kg/hr Group
Plasmalyte 3ml/kg/hr Group
CARE Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
daphne brockingtonLead Sponsor
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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