CompletedPhase 2NCT00141726

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

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.

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

StatusCompleted
PhasePhase 2
U.S. locations1
SponsorUniversity of Michigan Rogel Cancer Center
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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.

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

04
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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