Air flow obstruction after allogeneic SCT
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The prevention rate of decreasing respiratory function of the triplet combination treatment in AFO patinets | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Chiba University Hospital Department of Hematology