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

Study summary

The purpose of this study is to determine the effectiveness of etanercept in the treatment of patients with sub-acute lung injury following a bone marrow transplant. This study will also examine the toxicity of treatment with etanercept as well as whether there is an improved quality of life in these patients.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEtanercept

The study team can explain what participation involves.

Who it may be forLung Injury, Acute · Respiratory Distress Syndrome, Adult

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 3, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Michigan Rogel Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: University of Michigan Rogel Cancer Center
Interventions being studied: Drug: Etanercept

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Study topics

Survivorship and quality of life→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

The University of Michigan Cancer CenterAnn Arbor, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 3, 2015. Always confirm current availability with the study team.

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