Chronic graft versus host disease
Conditions
Interventions
ME3208 tablets are administered orally once daily. Subjects will visit the study site until the treatment discontinuation criteria are met or the study treatment is completed. The designated examinati
Sponsors
Kijima Koji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are able to provide written informed consent 2) Patients who received allogeneic hematopoietic cell transplantation (aHCT) 3) Patients diagnosed with moderate to severe chronic GVHD 4) Patients defined as steroid-dependent/refractory chronic GVHD at any time point after aHCT 5) Patients with the performance scale of 60 or more at baseline
Exclusion criteria
Exclusion criteria: 1) Patients with active acute GVHD 2) Patients with post-transplant lymphoproliferative disease 3) Patients with a severe past history or complications (malabsorption syndrome, poorly controlled psychiatric disease, coronary artery disease, etc.) that may affect the evaluation of this study as judged by the principal investigator or subinvestigator 4) Patients who cannot maintain medication adherence as judged by the principal investigator or subinvestigator 5) Patients for whom the principal investigator or subinvestigator judged that the implementation of this study is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: best overall response rate (best ORR) [Percentage of participants who achieve complete response (CR) or partial response (PR)] Safety: The safety are assessed by subjective symptoms, objective findings, physiological and clinical examinations. | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy of ME3208 are evaluated using duration of response (DOR), best ORR by organ and time point, time to response (TTR) , etc. as secondary outcomes. Evaluate the pharmacokinetics after administration of ME3208. | — |
Contacts
Public ContactKoji Kijima
Meiji Seika Pharma Co.,Ltd.
Outcome results
None listed