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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)

Chiba AFO-01 study (Chiba AFO-01 study)

Sakaida Emiko

Department of Hematology, Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba City, Chiba

esakaida@faculty.chiba-u.jp

Sakaida Emiko

Department of Hematology, Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba City, Chiba

+81-43-222-7171

esakaida@faculty.chiba-u.jp

Complete

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. The patient who receives 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

Both

Air flow obstruction after allogeneic SCT

treatment with budesonide/formoterol fumarate hydrate, clarithromycin, and montelukast

Air flow obstruction, allogeneic stem cell transplantation

treatment for AFO

The prevention rate of decreasing respiratory function of the triplet combination treatment in AFO patients

Efficacy:
1) incidence of AFO in allogeneic stem cell transplant 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 the intervention of immunosuppressant
7) QOL assessment by CATS scoring
Safety:
1) adverse events during the treatment
2) incidence of infectious episode

+81-43-226-2616

none