Chiba AFO-01 study

JRCT ID: jRCTs031180338

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Air flow obstruction after allogeneic SCT
• Date of first enrollment: 18/03/2019
• Target sample size: 85
• Study type: Interventional
• Intervention(s): treatment with budesonide/formoterol fumarate hydrate, clarithromycin, and montelukast

Outcome(s)

• Primary Outcome: The prevention rate of decreasing respiratory function of the triplet combination treatment in AFO patients

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

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

Exclude 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

Related Information

• Primary Sponsor: Sakaida Emiko
• Secondary ID(s): UMIN000022048