Glasdegib in Refractory Patients With Sclerotic Chronic Graft-Versus-Host Disease
Status:
Active, not recruiting
Trial end date:
2022-06-09
Target enrollment:
Participant gender:
Summary
This is a phase 1b/2a, open label, multi-centre, safety and efficacy study of glasdegib in
patients with sclerotic cGVHD refractory to second-line treatment. The design for the current
study is a standard 3+3 dose-finding scheme. A dose escalation/de-escalation design will be
applied in successive patient cohorts until identification of MTD. Glasdegib will be
self-administered orally once daily in the morning as monotherapy in continuous 28-day
treatment cycles for a maximum of 24 cycles. Those patients enrolled in the trial that obtain
objective clinical benefit under treatment with glasdegib (defined as the achievement of at
least a partial response at one or more target organs), will be allowed to proceed to a slow
dose withdrawal phase over a period of 6 months after the end of Cycle 24.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Grupo Espanol de trasplantes hematopoyeticos y terapia celular