Gvhd Resistant to ruxolitinib and steroids
Conditions
Brief summary
Overall response rate (ORR) on day 28, defined as the sum of complete and partial responses according to modified MAGIC/Glucksberg criteria.
Detailed description
ORR at day 56 and at 3 months, Best overall response within 3 months, Duration of response, Cumulative corticosteroid dose up to day 56 and at 3 months, Overall survival (OS) and progression-free survival (PFS) at 6 and 12 months, Non-relapse mortality (NRM) at 3, 6, and 12 months, Incidence of chronic GvHD at 12 months, Rate of corticosteroid discontinuation, Impact on quality of life (EQ-5D) at end of treatment and during follow-up, Safety profile up to 12 months, including incidence of serious adverse events, late infections, and product-related toxicities
Interventions
DRUGMC0518
Sponsors
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) on day 28, defined as the sum of complete and partial responses according to modified MAGIC/Glucksberg criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR at day 56 and at 3 months, Best overall response within 3 months, Duration of response, Cumulative corticosteroid dose up to day 56 and at 3 months, Overall survival (OS) and progression-free survival (PFS) at 6 and 12 months, Non-relapse mortality (NRM) at 3, 6, and 12 months, Incidence of chronic GvHD at 12 months, Rate of corticosteroid discontinuation, Impact on quality of life (EQ-5D) at end of treatment and during follow-up, Safety profile up to 12 months, including incidence of serious adverse events, late infections, and product-related toxicities | — |
Outcome results
None listed