Effectiveness of Etanercept for Idiopathic Pneumonia Syndrome Following Stem Cell Transplantation (BMT CTN 0403)

Study summary

The study is designed as a Phase III, multi-center randomized, double-blind, placebo-controlled trial investigating the use of etanercept for the treatment of acute, non-infectious pulmonary dysfunction (IPS) occurring after allogeneic hematopoietic cell transplantation (HCT).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEtanercept and Placebo plus corticosteroid

The study team can explain what participation involves.

Who it may be forPneumonia · Idiopathic Pneumonia Syndrome

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 1, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?National Heart, Lung, and Blood Institute (NHLBI)

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Interventions being studied: Drug: Etanercept; Drug: Placebo plus corticosteroid

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How this study is categorized

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

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

Patients fulfilling the following criteria will be eligible for registration in this study:
Recipient of an allogeneic bone marrow, cord blood, or peripheral blood stem cell transplant. There are no restrictions based upon underlying disease, donor source, degree of human leukocyte antigen (HLA) match, intensity of the pre-transplant conditioning regimen, or the use of a prior donor leukocyte infusion
Evidence of acute lung injury, based upon the presence of bilateral pulmonary infiltrates (on chest radiograph) and a supplemental oxygen requirement
No more than 180 days post transplant Patients fulfilling the following criteria will be eligible for random assignment in this study:
BAL fluid negative for pathogenic microorganisms as assessed by gram stain and fungal stain
BAL fluid negative for pathogenic microorganisms, or test result pending, as assessed by the following tests: 1. Acid fast bacilli stain (AFB) 2. Bacterial culture (a quantitative culture of at least 10(4) CFU/mL is considered positive) 3. Viral cultures for respiratory pathogens, including Respiratory syncytial virus (RSV), adenovirus, parainfluenza, influenza A and B, and Cytomegalovirus (CMV) 4. Fungal and mycobacterial cultures 5. Pneumocystis carinii pneumonia (PCP) assay, by polymerase chain reaction (PCR), direct fluorescent antibody (DFA) stain, or cytology (per institutional guidelines)

Reasons someone may not be able to joinExclusion criteria

Sepsis syndrome or hypotension in which inotropic support (excluding dopamine of no more than 5 mcg/kg/minute) is required
Bacteremia within 48 hours prior to study registration
Documented invasive fungal or systemic viral infection (excluding asymptomatic viruria) within 14 days prior to study registration
Evidence of CMV infection, based upon an abnormal PCR assay, antigenemia assay, or shell vial culture within 14 days of study registration
On mechanical ventilation for more than 48 hours at study registration
Evidence of congestive heart failure by clinical assessment
Participating in other investigational studies (Phase I, II, or III) for the treatment of acute GVHD within 7 days of study registration (patients enrolled in BMT CTN 0302 are ineligible for study entry)
Received etanercept within 14 days prior to study registration
Pregnant or breastfeeding
On more than 2 mg/kg/day of methylprednisolone equivalent for more than 48 hours, within 7 days prior to study registration
Known hypersensitivity to etanercept
History of active tuberculosis (TB) infection
History of chronic active hepatitis B or hepatitis C infection
Patients who have undergone a BAL within 72 hours of study registration are ineligible if the BAL fluid is known to be positive for pathogenic microorganisms
Patients who have relapsed or have developed progressive disease post-transplant

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

University of Florida College of Medicine (Shands)Gainesville, Florida
Indiana University Medical CenterIndianapolis, Indiana
Johns Hopkins UniversityBaltimore, Maryland
DFCI/Partners Cancer CenterBoston, Massachusetts
University of Michigan Medical CenterAnn Arbor, Michigan
University of MinnesotaMinneapolis, Minnesota
Mayo ClinicRochester, Minnesota
University of Nebraska Medical CenterOmaha, Nebraska
Memorial Sloan Kettering Cancer CenterNew York, New York
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania
University of Texas/MD Anderson Cancer CenterHouston, Texas
Fred Hutchinson Cancer Research CenterSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 1, 2021. Always confirm current availability with the study team.

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