Pneumonia Clinical Trial
Official title:
A Randomized Double-Blind, Placebo-Controlled Trial of Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Idiopathic Pneumonia Syndrome Following Allogeneic Cell Transplantation (BMTCTN0403)
Verified date | August 2017 |
Source | National Heart, Lung, and Blood Institute (NHLBI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 37 |
Est. completion date | July 2013 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion 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) Exclusion 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Medical Center | Ann Arbor | Michigan |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | DFCI/Partners Cancer Center | Boston | Massachusetts |
United States | University of Florida College of Medicine (Shands) | Gainesville | Florida |
United States | University of Texas/MD Anderson Cancer Center | Houston | Texas |
United States | Indiana University Medical Center | Indianapolis | Indiana |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program |
United States,
Yanik GA, Horowitz MM, Weisdorf DJ, Logan BR, Ho VT, Soiffer RJ, Carter SL, Wu J, Wingard JR, Difronzo NL, Ferrara JL, Giralt S, Madtes DK, Drexler R, White ES, Cooke KR. Randomized, double-blind, placebo-controlled trial of soluble tumor necrosis factor — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate | Response will be defined as survival to Day 28 of study, plus discontinuation of all supplemental oxygen support for more than 72 consecutive hours by Day 28. | Day 28 | |
Secondary | Response to Therapy | Response will be defined as the ability to survive to Day 56 of study, plus the ability to completely discontinue all supplemental oxygen support for > 72 consecutive hours during this time period. | Day 56 | |
Secondary | Discontinuation of Supplemental Oxygen | The "time required to discontinue supplemental oxygen" will be measured in the number of days from study entry. | Day 56 | |
Secondary | Corticosteroid Dose | Patients were treated with systemic corticosteroids with methylprednisolone at 2 mg/kg/day on day 0, with taper allowed after day 7. | Day 14 and 28 | |
Secondary | Overall Survival | Percentage of patients that survived after one year | Year 1 | |
Secondary | Incidence of Infection | Day 56 | ||
Secondary | Incidence of Toxicity | Day 56 | ||
Secondary | Incidence of Graft-vs-Host-Disease (GVHD) | Year 1 | ||
Secondary | Incidence of Relapse | Percentage of patients who experience relapse. Deaths without relapse are considered as a competing risk. | Year 1 | |
Secondary | Overall Mortality | Year 2 | ||
Secondary | Dermatologic Reaction | Day 28 | ||
Secondary | Pro-inflammatory Markers of Pulmonary Disease, in Both BAL Fluid and Plasma | Day 28 |
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