UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010750
Receipt number 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 15:07:23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Fukuoka Blood and Marrow Transplantation Group

Institute

Department

Personal name



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

Value
https://center6.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