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

This study has been completed.
Sponsor:
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
National Marrow Donor Program
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00421174
First received: January 9, 2007
Last updated: August 11, 2016
Last verified: August 2016
Results First Received: January 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Pneumonia
Idiopathic Pneumonia Syndrome
Interventions: Drug: Etanercept
Drug: Placebo plus corticosteroid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled from September 2007 to August 2011 from 12 different sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Etanercept Etanercept plus corticosteroids
Placebo Placebo plus Corticosteroids

Participant Flow:   Overall Study
    Etanercept   Placebo
STARTED   18   19 
COMPLETED   16   18 
NOT COMPLETED   2   1 
Withdrawal by Subject                0                1 
Ineligible due to infection                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Etanercept Etanercept plus corticosteroids
Placebo Placebo plus Corticosteroids
Total Total of all reporting groups

Baseline Measures
   Etanercept   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   18   34 
Age 
[Units: Years]
Median (Full Range)
 47.7 
 (22.9 to 70.1) 
 46.4 
 (21.8 to 68.8) 
 46.6 
 (21.8 to 70.1) 
Gender 
[Units: Participants]
     
Female   8   10   18 
Male   8   8   16 
Primary Disease 
[Units: Participants]
     
Acute Myelogenous Leukemia (AML)   1   9   10 
Myelodysplastic Syndrome (MDS)   2   2   4 
Acute Lymphoblastic Leukemia (ALL)   3   4   7 
Lymphoma   3   0   3 
Other   7   3   10 
Karnofsky Performance [1] 
[Units: Participants]
     
70 - 90   3   1   4 
50 - 60   5   5   10 
< 50   5   10   15 
Unknown   3   2   5 
[1] Assesses patient self-perceived global quality of life and functioning (excellent = 100, good = 70-90, fair = 50-60, poor < 50), where 100 equals perfect quality of life.
Conditioning Regimen 
[Units: Participants]
     
Myeloablative   9   11   20 
Non-myeloablative   7   7   14 
Recipient Cytomegalovirus Status 
[Units: Participants]
     
Positive   8   10   18 
Negative   8   7   15 
Unknown   0   1   1 
Total Bilirubin [1] 
[Units: Mg/dl]
Median (Full Range)
 1.2 
 (0.2 to 18.9) 
 0.9 
 (0.2 to 10.7) 
 1.0 
 (0.2 to 18.9) 
[1] Serum total bilirubin (mg/dl) at study entry.
Creatinine [1] 
[Units: Mg/dl]
Median (Full Range)
 1.3 
 (0.6 to 2.5) 
 1.4 
 (0.4 to 2.9) 
 1.3 
 (0.4 to 2.9) 
[1] Serum creatinine (mg/dl) at study entry.
Oxygen Support [1] 
[Units: Participants]
     
Nasal cannula   10   6   16 
Face mask   3   5   8 
Mechanical ventilation   2   6   8 
Unknown   1   1   2 
[1] Method of supplemental oxygen support at study entry.


  Outcome Measures
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1.  Primary:   Response Rate   [ Time Frame: Day 28 ]

2.  Secondary:   Response to Therapy   [ Time Frame: Day 56 ]

3.  Secondary:   Discontinuation of Supplemental Oxygen   [ Time Frame: Day 56 ]

4.  Secondary:   Corticosteroid Dose   [ Time Frame: Day 14 and 28 ]

5.  Secondary:   Overall Survival   [ Time Frame: Year 1 ]

6.  Secondary:   Incidence of Infection   [ Time Frame: Day 56 ]

7.  Secondary:   Incidence of Toxicity   [ Time Frame: Day 56 ]

8.  Secondary:   Incidence of Graft-vs-Host-Disease (GVHD)   [ Time Frame: Year 1 ]

9.  Secondary:   Cumulative Incidence of Relapse   [ Time Frame: Year 1 ]

10.  Secondary:   Overall Mortality   [ Time Frame: Year 2 ]

11.  Secondary:   Dermatologic Reaction   [ Time Frame: Day 28 ]

12.  Secondary:   Pro-inflammatory Markers of Pulmonary Disease, in Both BAL Fluid and Plasma   [ Time Frame: Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Adam Mendizabal, PhD
Organization: The EMMES Corporation
phone: (301) 251-1161 ext 221
e-mail: amendizabal@emmes.com


Publications of Results:

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00421174     History of Changes
Other Study ID Numbers: BMTCTN0403
BMT CTN 0403 ( Other Identifier: Blood and Marrow Transplant Clinicial Trials Network )
U01HL069294-05 ( US NIH Grant/Contract Award Number )
465 ( Other Identifier: BMT CTN )
Study First Received: January 9, 2007
Results First Received: January 28, 2016
Last Updated: August 11, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board