Non-infectious lung complications after allogeneic stem cell transplantation
Conditions
Interventions
Etanercept is administered subcutaneously at a dose of 25mg/body, twice weekly (72-96 hours between doses), for total of 8 doses (4-week course).
Sponsors
Department of hematology, Hamamatsu university school of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients older than 16 years 2. Signed informed consent by patients themselves or their proxies to participate as a subject in this study 3. Patients with non-infectious lung complications after allogeneic stem cell transplantation and an oxygen saturation (SpO2) 93% or below in room air or 93% or above in inhaled oxygen
Exclusion criteria
Exclusion criteria: 1. Patients who do not consent to this study 2. Patients considered ineligible for this study by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the complete response rate at day 28 after administration of etanercept. The complete response rate is defined as the percentage of the patients with SpO2 93% or above on room air for 72 hours or above. The patients with SpO2 93% or above on room air after day 26 will be assessed after 72 hours from the achievement of SpO2 93% or above. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rate at day 28 after administration of etanercept The response rate is included in the complete response rate and the partial response rate. The partial response rate is defined as the percentage of the patients with SpO2 93% or above for 72 consecutive hours by at least 50% or below of oxygen support requirements before the start of treatment. 2. Duration from the start of treatment until the first day of independent of oxygen support for 72 hours 3. Overall survival at day 28 and 1 year after the start of treatment 4. Adverse effect such as infection and reaction on injection site, laboratory data and the results of X-ray and CT scan 5. The levels of cytokines prior to administration of etanercept, at day 15 days and day 29 after treatment, and the association between these data and response rate 6.The association between patient characteristics and response rate | — |
Countries
Japan
Contacts
Public ContactMiwa Adachi
Hamamatsu university school of medicine Department of hematology
Outcome results
None listed