Treatment of acute graft-versus host disease (aGvHD) to the gastrointestinal (GI) tract of patients who are resistant or intolerant to ruxolitinib.
Conditions
Brief summary
To evaluate the efficacy of MaaT013 assessed by the overall response rate (ORR) of gastrointestinal (GI) acute grfat-versus-host disease (aGVHD) response at day 28 (D28).
Detailed description
To evaluate MaaT013 safety, To evalutae ORR for GI at D56 and M3, To evaluate ORR for all organs at D28, D56 and M3, To evaluate the best ORR (for GI and all organs) acheived between D0 and D28, To assess duration of response, To assess overall survival (OS), To assess progression-free survival (PFS), To assess time to progression, To assess steroid-free survival, To evaluate the frequency of patients that tapered off CS, To measure the incidence of chronic GvHD, To evaluate changes in patient reported outcomes (PROs)
Interventions
DRUGMaaT013
Sponsors
MaaT PHARMA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of MaaT013 assessed by the overall response rate (ORR) of gastrointestinal (GI) acute grfat-versus-host disease (aGVHD) response at day 28 (D28). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate MaaT013 safety, To evalutae ORR for GI at D56 and M3, To evaluate ORR for all organs at D28, D56 and M3, To evaluate the best ORR (for GI and all organs) acheived between D0 and D28, To assess duration of response, To assess overall survival (OS), To assess progression-free survival (PFS), To assess time to progression, To assess steroid-free survival, To evaluate the frequency of patients that tapered off CS, To measure the incidence of chronic GvHD, To evaluate changes in patient reported outcomes (PROs) | — |
Countries
Austria, Belgium, France, Germany, Italy, Spain
Outcome results
None listed