UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	FBMTG BDP17
Region	Japan

Condition
Condition	Hematologic disorders Gastrointestinal acute GVHD
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of oral Beclometasone dipropionate (BDP) in patients with grade IIa gastrointestinal acute GVHD after allogeneic transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of treatment success at 50 days after starting oral BDP
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral BDP (10ml liquid formulation plus pills 1.3 mg/day in four divided doses as gastric-release formulation)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key 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
Key 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.
Target sample size	35

Research contact person
Name of lead principal investigator	Goichi Yoshimoto
Organization	Kyushu University Hospital
Division name	Hematology and Oncology
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5315
Email	fbmtg@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person	FBMTG Study Office
Organization	FBMTG
Division name	FBMTG Study Office
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5315
Homepage URL
Email	fbmtg@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	FBMTG
Institute
Department

Funding Source
Organization	Research Foundation for Community Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 12 Month 20 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 02 Day
Last modified on	2017 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028880