Table 2.

Preemptive trials for aGvHD

ClinicalTrials.gov Identifier:AgeRisk assignmentNo. of patientsExpected completionInterventionOutcome to be measuredImproved outcomeRef.
NCT05368181
Chengdu, Sichuan, China 
Adult High risk by MAP days 7, 14, 21, 28 56 Dec 2024 Methylprednisolone starts with the dose of 2  mg/kg for 5 days High Risk Patients Who Develop Grade III-IV aGvHD by day 100 Pending NA 
NCT03459040
MAGIC consortium 
Adults High risk by day 7 or 14 30 Completed α1-Antitrypsin Number of High Risk patients who develop steroid refractory GvHD by day 100 No  
EudraCT number: 2008-005862-30. aGvHD MS-17 Adults High risk 14 days before onset 92 Completed Prednisolone 2-2.5  mg/kg for 5 days followed by a taper of 19 days in the absence of aGvHD Incidence of aGvHD II-IV between randomization and day +100 after HSCT No  
Bagialupo Adults High risk by day 7 170 Completed ATG 1.25  mg/kg intravenously on days 7 and 9 Primary end point of the study was TRM
Secondary end point was acute GvHD grades 3 to 4. 
Decreased aGvHD 10  
Storek Adults High risk on day 7 68 Completed ATG day 8 Reduction in high risk GvHD (both aGvHD and cGvHD) No 42 
ClinicalTrials.gov Identifier:AgeRisk assignmentNo. of patientsExpected completionInterventionOutcome to be measuredImproved outcomeRef.
NCT05368181
Chengdu, Sichuan, China 
Adult High risk by MAP days 7, 14, 21, 28 56 Dec 2024 Methylprednisolone starts with the dose of 2  mg/kg for 5 days High Risk Patients Who Develop Grade III-IV aGvHD by day 100 Pending NA 
NCT03459040
MAGIC consortium 
Adults High risk by day 7 or 14 30 Completed α1-Antitrypsin Number of High Risk patients who develop steroid refractory GvHD by day 100 No  
EudraCT number: 2008-005862-30. aGvHD MS-17 Adults High risk 14 days before onset 92 Completed Prednisolone 2-2.5  mg/kg for 5 days followed by a taper of 19 days in the absence of aGvHD Incidence of aGvHD II-IV between randomization and day +100 after HSCT No  
Bagialupo Adults High risk by day 7 170 Completed ATG 1.25  mg/kg intravenously on days 7 and 9 Primary end point of the study was TRM
Secondary end point was acute GvHD grades 3 to 4. 
Decreased aGvHD 10  
Storek Adults High risk on day 7 68 Completed ATG day 8 Reduction in high risk GvHD (both aGvHD and cGvHD) No 42 

NA, not available; TRM, transplant related mortality.

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