Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PredEver · 1 trial · 1 indication
Patient being alive and having achieved a CR or PR of cGvHD without addition of secondary systemic treatment for cGvHD (see below) and without development of relapse of underlying disease. Addition of any immunosuppressive or immunomodulatory systemic therapy aimed at treating or controlling symptoms of chronic GvHDcGvHD is considered treatment failure. Examples of secondary systemic therapies include (but are not limited to) cyclosporine ACSA, tacrolimus, methotrexate, mycophenolate, rituximab, azathioprine, pentostatine, cyclophosphamid, chloroquine, imatinib, dasatinib, thalidomide, alemtuzumab, etanercept, antithymocyte globulin, infliximab, basiliximab, daclizumab, extracorporeal photopheresis, psoralen with UVA-irradiation (PUVA), pulsed steroid exceeding a dose of 2 mg/kg/day.
| Arm | Type | Description |
|---|---|---|
| PredEver | EXPERIMENTAL | Prednisone and Everolimus |
| Name | Type | Description |
|---|---|---|
| PredEver | DRUG | Firstline treatment with prednisone and Everolimus |
Inclusion Criteria: 1. Patient's written informed consent 2. Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, intrauterine devices, oral contraceptives) until three months after termination of treatment 3. Age ≥ 18 years 4. Diagnosis of classic chroni...