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An exploratory study of administration of Etanercept for patients with idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell trasnplantation

An exploratory study of administration of Etanercept for patients with idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell trasnplantation - Etanercept for IPS after allogeneic HSCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017738
Enrollment
20
Registered
2015-05-29
Start date
2009-10-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell transplantation

Interventions

Subcutaneous administration of etanercept, 0.4 mg/kg (max 25 mg) 2 times a week for four weeks.

Sponsors

Univesity of Tokyo Hospital, Department of Hematology and Oncology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who have received allogeneic hematopoietic stem cell transplantation. (2) Patients with IPS. NIH criteria for IPS (a) multilobar infiltrates on CXR or CT. (b) Clinical signs of pneumonia: cough, dyspnea, or rales. (c) Abnormal physiology: increased arterial-alveolar oxygen gradient, or the need for supplemental oxygen support. (d) Negative BAL for bacterial and nonbacterial organisms. (e) Negative surgical lung biopsy. (a), (b) and (c) were all fulfilled and (d) or (e) was also fulfilled. (3) patients equal or older than 20 yo. (4) written informed consent was obtained.

Exclusion criteria

Exclusion criteria: (1) patients without enough . (2) the presence of any of the following after at the time of enrollment. (a) an active pulmonary infection as determined by positive culture of bronchoalveolar lavage (BAL) fluid. (b) hypotension in which inotropic support other than dopamine was required. (c) bacteremia within 48 hours before study entry. (d) CMV viremia. (e) systemic fungal or other nonbacterial infections. (f) clinical or echocardiographic evidence for cardiac dysfunction as the cause of respiratory failure. (3) pregnancy or lactating.

Design outcomes

Primary

MeasureTime frame
withdrawal rate from oxygenation

Secondary

MeasureTime frame
1-year overall survival

Countries

Japan

Contacts

Public ContactAkira Honda

Univesity of Tokyo Hospital Hematology and Oncology

ahonda-spr@umin.org03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026