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Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study


Phase 2
6 Years
N/A
Open (Enrolling)
Both
Lung Injury, Acute, Respiratory Distress Syndrome, Adult, Bronchiolitis Obliterans

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Trial Information

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study


Lung or breathing problems can develop several months to years following a bone marrow
transplant. In some cases, these breathing problems develop without any signs of germs or
infection in the lungs. The name for this type of breathing problem is called "Sub-Acute
Lung Injury". Sub-acute lung injury often develops many months, even years following a bone
marrow transplant. It is often characterized by shortness of breath, cough, wheezing and
fatigue.

Sub-acute lung injury can either lead to the formation of scar tissue in the lungs (making
it difficult to take deep breaths), or it can cause the lungs to get weak (making people
feel out of breath easily). Approximately 25 - 50% of patients with sub-acute lung injury
may eventually die from the damage in their lungs. Typically, such patients die from
infections that develop inside the damaged lungs.

In this study, treatment with an experimental drug called Etanercept will be used.
(Enbrel). The physicians feel there is the possibility that Etanercept may help improve
breathing. Breathing ability will be assessed prior to treatment as well as during and after
treatment so that comparisons can be made.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the response to etanercept therapy, based upon pulmonary function parameters (FEV1.0, FEV1.0/FVC, DLCO) in patients with sub-acute lung injury > 100 days post transplant

Outcome Time Frame:

week 12 post therapy

Safety Issue:

Yes

Principal Investigator

Gregory A Yanik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Michigan Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 3-31

NCT ID:

NCT00141726

Start Date:

October 2003

Completion Date:

December 2013

Related Keywords:

  • Lung Injury, Acute
  • Respiratory Distress Syndrome, Adult
  • Bronchiolitis Obliterans
  • Enbrel
  • Stem Cell Transplantation
  • Lung Injury
  • Bronchiolitis
  • Bronchiolitis Obliterans
  • Respiratory Distress Syndrome, Newborn
  • Respiratory Distress Syndrome, Adult
  • Acute Lung Injury
  • Lung Injury

Name

Location
The University of Michigan Cancer Center Ann Arbor, Michigan  48109