Unique ID issued by UMIN | UMIN000022048 |
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Receipt number | R000025413 |
Scientific Title | The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT |
Date of disclosure of the study information | 2016/04/25 |
Last modified on | 2021/10/29 12:29:28 |
The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT
Chiba AFO-01 study
The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT
Chiba AFO-01 study
Japan |
Air flow obstruction after allogeneic SCT
Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in patinets with AFO after allogeneic SCT
Safety,Efficacy
Confirmatory
The prevention rate of decreasing respiratory function of the triplet combination treatment in AFO patinets
Efficacy:
1) incidence of AFO in allogeneic stem cell ytansplant recipients
2) the rate of symptom improvement after intervention with triplet combination therapy
3) the rate of the detection of radiologic abnormality, and improvement
4) the correlation between the occurrence of AFO and chronic GVHD
5) OS, NRM, relapse rate
6) the rate of intervention of immunosuppressant
7) QOL assessment by CATS scoring
Safety:
1) adverse events dueing the treatment
2) incidence of infectious episode
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
1
Treatment
Medicine |
The patients who diagnosed as AFO start the combination treatment, includind butesonid/formoterol fumarate, clarjthromycin, and monterkast, immediately. If feasible, continue the triplet combination therapy for one year after diagonosis of AFO.
16 | years-old | <= |
70 | years-old | > |
Male and Female
1. The patient who receive the 1st allogeneic stem cell transplantation
2. The patient who can examine the pulmonary function tests.
3. PS (ECOG), 0-2
4. The patient who has no exceptionable organ problems
1) serum ALT/AST concentrations:150 IU/L and under
2) total bilirubin: 3mg/dL and under
3) CCr:40ml/min or over (by C-G)
4) arterial blood oxygen saturation or SpO2 in room air:94% or over
5. Written informed consent
1. Known history of intolerance or allergy to any triplet component.
2. The patient who has past history of asthma and had attack within one year.
3. The patient who has already been treated with the triplet combination.
4. The patient who has active infection
5. The patient who has mental disability requiring treatment
6. The patient who has severe thromboembolism, including myocardial infarction, cerebral infarction, and cardiovascular complications.
7. The patient who has uncontrollable diabetes mellitus and metabolic disease
8. The patient who has other malignancy requiring anticancer treatment
9. Pregnancy or nursing.
10. At the time of enrollment as judged by the enrolling investigator would interfere
with the subjects ability to comply with the study requirements
60
1st name | Emiko |
Middle name | |
Last name | Sakaida |
Chiba University Hospital
Department of Hematology
2608677
1-8-1, inohana, Chuo-ku, Chiba
043-222-7171
chiaki-nakaseko@faculty.chiba-u.jp
1st name | Emiko |
Middle name | |
Last name | Sakaida |
Chiba University Hospital
Department of Hematology
2608677
1-8-1, inohana, Chuo-ku, Chiba
043-222-7171
esakaida@faculty.chiba-u.jp
Department of Hematology, Chiba University Hospital
Department of Hematology, Chiba University Hospital
Other
Chiba University Hospital
1-8-1, inohana, Chuo-ku, Chiba
043-222-7171
esakaida@faculty.chiba-u.jp
NO
千葉大学病院、青葉病院、成田赤十字病院、旭中央病院
2016 | Year | 04 | Month | 25 | Day |
Unpublished
85
No longer recruiting
2016 | Year | 01 | Month | 28 | Day |
2016 | Year | 06 | Month | 19 | Day |
2016 | Year | 06 | Month | 20 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 11 | Month | 30 | Day |
2022 | Year | 06 | Month | 30 | Day |
2016 | Year | 04 | Month | 25 | Day |
2021 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025413
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