T-Guard for Graft-vs-Host Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Graft-vs-Host Disease+1 More
T-Guard - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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
  • Graft-vs-Host Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Days 6, 14, 28, and 56

Day 180
Chronic GVHD (cGVHD)
Relapse-free Survival (RFS)
Relapse/Progression of Underlying Malignancy
Day 28
Complete Response (CR)
Duration of Complete Response (DoCR)
Day 56
Incidence of Toxicities
Day 90
Incidence of Infections
Day 14
Overall Response Rate (ORR)
Days 28 and 56
Time to Complete Response (CR)
Day 6
Proportion of Response
Day 60
Overall Survival (OS)
Days 90 and 180
GVHD-free Survival
Non-relapse Mortality (NRM)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Ruxolitinib
1 of 2
T-Guard
1 of 2
Active Control
Experimental Treatment

246 Total Participants · 2 Treatment Groups

Primary Treatment: T-Guard · No Placebo Group · Phase 3

T-Guard
Drug
Experimental Group · 1 Intervention: T-Guard · Intervention Types: Drug
Ruxolitinib
Drug
ActiveComparator Group · 1 Intervention: Ruxolitinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ethanol
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days 6, 14, 28, and 56

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,991 Previous Clinical Trials
41,298,247 Total Patients Enrolled
National Marrow Donor ProgramOTHER
59 Previous Clinical Trials
182,317 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,576 Previous Clinical Trials
46,968,335 Total Patients Enrolled
XenikosLead Sponsor
2 Previous Clinical Trials
23 Total Patients Enrolled
Blood and Marrow Transplant Clinical Trials NetworkNETWORK
49 Previous Clinical Trials
14,015 Total Patients Enrolled
Willem KlaasenStudy DirectorXenikos, BV
Mary Horowitz, MD, MSStudy DirectorCenter for International Blood and Marrow Transplant Research
12 Previous Clinical Trials
3,684 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
or total cumulative dose of 60 mg If someone takes more than 60 mg of methylprednisolone in 3 days or less, they are likely to experience new organ involvement.
There was no improvement after seven days of primary treatment with methylprednisolone (or equivalent) of greater than or equal to 2mg/kg/day.
Patients who began treatment with methylprednisolone (or equivalent) and had improvement in skin GVHD but not visceral GVHD after seven days were given a greater than or equal to 2mg/kg/day dose.
After myeloid engraftment is confirmed, patients may receive growth factor supplementation.
The patient or someone else who is not involved in their care (in case the patient is not capable of providing verbal consent but capable of signing the ICF) should have given written consent.
Patients who have skin GVHD and develop visceral aGVHD during treatment with methylprednisolone (or equivalent) of greater than or equal to 1mg/kg/day and do not improve after 3 days of greater than or equal to 2mg/kg/day are considered to have organ improvement or progression.
In order to provide consent for treatment, the patient must be at least 18 years old.
Patients who have undergone an allo-HSCT from any donor source or graft source are eligible

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.