The efficacy and safety of oral Beclomethasone dipropionate (BDP) in patients with gastrointestinal acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation FBMTG BDP17
Not Applicable
- Conditions
- Hematologic disorders Gastrointestinal acute GVHD
- Registration Number
- JPRN-UMIN000025116
- Lead Sponsor
- FBMTG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of treatment success at 50 days after starting oral BDP
- Secondary Outcome Measures
Name Time Method 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