UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025116 |
|---|---|
| Receipt number | R000028880 |
| 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 FBMTG BDP17 |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2017/07/28 09:56:56 |
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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 FBMTG BDP17
Acronym
FBMTG BDP17
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 FBMTG BDP17
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Goichi Yoshimoto |
Organization
Kyushu University Hospital
Division name
Hematology and Oncology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5315
fbmtg@intmed1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | FBMTG Study Office |
Organization
FBMTG
Division name
FBMTG Study Office
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5315
Homepage URL
fbmtg@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
FBMTG
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028880
