Chiba AFO-01 study

Phase 2

• Conditions: Air flow obstruction after allogeneic SCT; Air flow obstruction, allogeneic stem cell transplantation

• Registration Number: JPRN-jRCTs031180338
• Lead Sponsor: Sakaida Emiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 85

Inclusion 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy:<br>1) incidence of AFO in allogeneic stem cell transplant recipients<br>2) the rate of symptom improvement after intervention with triplet combination therapy <br>3) the rate of the detection of radiologic abnormality, and improvement <br>4) the correlation between the occurrence of AFO and chronic GVHD<br>5) OS, NRM, relapse rate<br>6) the rate of the intervention of immunosuppressant <br>7) QOL assessment by CATS scoring<br>Safety:<br>1) adverse events during the treatment<br>2) incidence of infectious episode