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T-Guard for Acute Graft-versus-Host Disease (2002 Trial)

Phase 3
Waitlist Available
Research Sponsored by Xenikos
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 days 6, 14, 28, and 56
Awards & highlights

2002 Trial Summary

This trial is testing whether T-Guard is more effective and safe than ruxolitinib for treating patients with severe steroid-refractory Graft-Versus-Host Disease.

Eligible Conditions
  • Steroid Refractory Acute Graft Versus Host Disease

2002 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 6, 14, 28, and 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 6, 14, 28, and 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR)
Secondary outcome measures
Chronic GVHD (cGVHD)
Duration of Complete Response (DoCR)
GVHD-free Survival
+9 more

2002 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: T-GuardExperimental Treatment1 Intervention
Participants will be administered four doses of T-Guard intravenously for a 4-hour period every other day
Group II: RuxolitinibActive Control1 Intervention
Participants will take ruxolitinib twice daily for continuous daily dosing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
T-Guard
2014
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

XenikosLead Sponsor
2 Previous Clinical Trials
23 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,484 Total Patients Enrolled
Blood and Marrow Transplant Clinical Trials NetworkNETWORK
49 Previous Clinical Trials
13,970 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still being signed up for this research project?

"That is accurate. The information available on clinicaltrials.gov shows that this study is currently looking for participants. This trial was first posted on June 16th, 2022 and has been updated as recently as November 2nd, 2022. They are trying to enroll 246 individuals at 24 different locations."

Answered by AI

What purpose does T-Guard typically serve?

"T-Guard is most often used as an ethylene glycol treatment, but it can also be employed to disinfect the skin, fight bacterial infections, and alleviate symptoms of polycythemia vera."

Answered by AI

Are there comparable research projects to T-Guard?

"T-Guard was first studied in the year 2002 at National Institutes of Health Clinical Center, 9000 Rockville Pike. To date there have been 231 completed trials. There are presently 144 live clinical trials, with many of these trials running out of Rochester, Minnesota."

Answered by AI

What is the total number of research facilities conducting this trial?

"There are 24 sites in total for this trial, but the main locations are Mayo Clinic (Rochester, Minnesota), City of Hope National Medical Center (Duarte, California), and University of Pennsylvania (Philadelphia, Pennsylvania)."

Answered by AI

What are the FDA's thoughts on T-Guard?

"T-Guard received a safety score of 3 because there is efficacy data and multiple rounds of safety data from Phase 3 trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)
2022. "A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04934670.
~4 spots leftby Apr 2025
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