Primary Treatment: T-Guard · No Placebo Group · Phase 3
Experimental Group · 1 Intervention: T-Guard · Intervention Types: Drug
ActiveComparator Group · 1 Intervention: Ruxolitinib · Intervention Types: Drug
Drug Approval Stage
How many patients have taken this drug
Screening: ~3 weeks
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
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
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
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.