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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 below

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
15%
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.

Find a Location

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.
~2 spots leftby Mar 2025