Unique ID issued by UMIN | UMIN000010750 |
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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 |
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-004
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-004
Japan |
Hematologic disorders
Gastrointestinal acute GVHD
Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy and safety of oral Beclometasone dipropionate (BDP) in patients with grade IIa gastrointestinal acute GVHD after allogeneic transplantation
Safety,Efficacy
Exploratory
Rate of treatment success at 49 days after starting oral BDP
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
16 | years-old | <= |
70 | years-old | > |
Male and Female
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
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.
35
1st name | |
Middle name | |
Last name | Koichi Akashi |
Kyushu University Hospital
Hematology and Oncology
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
1st name | |
Middle name | |
Last name | Takanori Teshima |
Kyushu University Hospital
Center for cellular and molecular medicine
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
092-642-5947
Fukuoka Blood and Marrow Transplantation Group
None
Self funding
NO
2013 | Year | 05 | Month | 17 | Day |
Unpublished
Completed
2008 | Year | 07 | Month | 01 | Day |
2008 | Year | 10 | Month | 01 | Day |
2014 | Year | 04 | Month | 30 | Day |
2014 | Year | 04 | Month | 30 | Day |
2014 | Year | 04 | Month | 30 | Day |
2014 | Year | 04 | Month | 30 | Day |
2013 | Year | 05 | Month | 17 | Day |
2014 | Year | 05 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012562
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