Hematologic disorders Gastrointestinal acute GVHD
Conditions
Interventions
Oral BDP (10ml liquid formulation plus pills 1.3 mg/day in four divided doses as gastric-release formulation)
Sponsors
FBMTG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with grade IIa gastrointestinal (GI) acute GVHD after allogeneic transplant (The diagnosis of upper GI GVHD must be histologically confirmed) 2) Patients who receive no treatment for GVHD 3) Patients who have ability to tolerate oral administration 4) Age 16-69 years 5) ECOG performance status of 0-2 6) Patients with adequate main organ function 7) Voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who receive bone marrow or peripheral blood stem cell transplantation from 2 or more HLA mismatched donor. 2) Patients with serious main organ dysfunction other than GVHD. 3) Patients who have history of serious hypersensitivity to any drug. 4) Pregnant, possibility pregnant or lactating female 5) Inability to follow the procedures required in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of treatment success at 50 days after starting oral BDP | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Treatment-related toxicity 2) Rates of treatment discontinuation due to toxicity 3) Relapse rates of acute GVHD by day 100 4) Incidence of bacterial, fungal, and viral infection including cytomegalovirus antigenemia | — |
Countries
Japan
Contacts
Public ContactFBMTG Study Office
FBMTG FBMTG Study Office
Outcome results
None listed