Etanercept for non-infectious lung complications after allogeneic stem cell transplantation

JRCT ID: jRCTs041180010

Registered date:30/10/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-infectious lung complications after allogeneic stem cell transplantation
• Date of first enrollment: 01/06/2018
• Target sample size: 20
• Study type: Interventional
• Intervention(s): 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).

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include 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 diagnosed as noninfectious pulmonary complications after transplantation after allogeneic hematopoietic stem cell transplantation, cases with oxygen saturation of less than 93% in the room air

Exclude criteria

1.Patients with obvious active lung infection
2.Patients who are thought to be involved in heart failure as a cause oh respiratory failure (Clear cardiac shadow enlargement finding was found in chest X-ray,and left ventricular ejection fraction less than 45%on echocardiogram)
3.Patients whose mental illness, psychiatric symptoms, and cognitive impairment are combined and judged to be difficult to participate in the study
4.Patients with uncontrollable complications (When treatment also has 300mg/dl or more of fasting blood sugar)
5.Other patients whose doctor judged that it is difficult to participate in the exam

Related Information

• Primary Sponsor: Ono Takaaki
• Secondary ID(s): UMIN000032737