Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00141726
• Date of registration: 30/08/2005
• Prospective Registration: No
• Primary sponsor: University of Michigan Cancer Center
• Public title: Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
• Scientific title: Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study
• Date of first enrolment: October 2003
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00141726
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Gregory A Yanik, MD
• Affiliation: The University of Michigan Comprehensive Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Recipients of allogeneic bone marrow, cord blood, or peripheral blood stem cell
transplants are eligible

- Age >6 years and able to complete pulmonary function testing

- Patients with evidence of sub-acute, non-infectious pulmonary dysfunction (OLD or RLD)

- Recipients of sub-ablative transplant regimens are eligible

- Recipients of donor leukocyte infusions (DLI) post-transplant are eligible

- Patients must be > 100 days post transplant

Exclusion Criteria:

- Patients with hypotension requiring inotropic agents other than dopamine < 5mcg/ kg/
minute for blood pressure support.

- Patients with a positive quantitative bacterial culture from the BAL fluid (= 104 CFU/
ml is considered positive)

- Patients whose BAL fluid is positive for significant bacterial pathogens or pathogenic
nonbacterial microorganisms (as defined by protocol) by special stain, culture or PCR
analysis

- Patients who are enrolled on a phase I or phase II trial for the prophylaxis or
treatment of GVHD (acute or chronic) within 7 days of study entry.

- Patients with known hypersensitivity to etanercept.

- Patients who are pregnant.

- Patients with CMV seropositivity at the time of study entry. Testing may include
wither CMV PCR analysis or CMV pp65 testing.

- Evidence for multi-system organ failure.



Age minimum: 6 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lung Injury, Acute

Bronchiolitis Obliterans

Respiratory Distress Syndrome, Adult

Intervention(s)

Drug: Etanercept

Primary Outcome(s)

Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO [Time Frame: week 12 post therapy]

Secondary Outcome(s)

Percentage of Participants That Experience Grade 3 to 4 Adverse Events [Time Frame: continuously (and week 4, week 8 and week 12, week 20)]

Secondary ID(s)

UMCC 3-31

IRBMED 2003-0590 and HUM 46747

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/06/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00141726