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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
Be older than 18 years old
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 Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

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 • NCT02135146
20%
Pulmonary Edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Plasmalyte 3ml/kg/hr Group
Plasmalyte 6ml/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.

Find a Location

Who is running the clinical trial?

daphne brockingtonLead Sponsor
~2 spots leftby Jun 2025
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