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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010750
Receipt No. R000012562
Scientific Title 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
Date of disclosure of the study information 2013/05/17
Last modified on 2014/05/23

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Basic information
Public title 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
Acronym FBMTG-004
Scientific Title 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
Scientific Title:Acronym FBMTG-004
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 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of treatment success at 49 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) for patients undergoing cord blood stem cell transplantation.
2) Predonisone (1mg/kg/day, iv) plus oral BDP (10ml liquid formulation plus pills 1.3 mg/day in four divided doses as gastric-release formulation) for patients undergoing bone marrow transplantation and peripheral blood stem cell transplantation.
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
1st name
Middle name
Last name Koichi Akashi
Organization Kyushu University Hospital
Division name Hematology and Oncology
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takanori Teshima
Organization Kyushu University Hospital
Division name Center for cellular and molecular medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5947
Homepage URL
Email

Sponsor
Institute Fukuoka Blood and Marrow Transplantation Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 05 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
2014 Year 04 Month 30 Day
Date trial data considered complete
2014 Year 04 Month 30 Day
Date analysis concluded
2014 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 17 Day
Last modified on
2014 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012562

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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