Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421174
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2007-01-09
Brief Title:
Effectiveness of Etanercept for Idiopathic Pneumonia Syndrome Following Stem Cell Transplantation BMT CTN 0403
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
BACKGROUND
Over the last two decades allogeneic hematopoietic cell transplantation HCT has emerged as an important treatment for a number of malignant and non-malignant disorders Unfortunately several complications including graft-versus-host disease GVHD and pulmonary dysfunction limit the utility of this aggressive form of therapy Infectious and non-infectious lung complications occur in 25 to 55 of HCT recipients and account for up to 50 of transplant-related mortality In about half of affected patients no infectious organisms are identified in the lungs Two major types of non-infectious pulmonary injury are recognized acute idiopathic pneumonia syndrome IPS and sub-acute lung injury obstructive airway disease or bronchiolitis obliterans BrOb and restrictive lung disease The current study will examine the use of etanercept in patients with IPS
DESIGN NARRATIVE
Eligible patients will be randomized to receive one of two arms of therapy A etanercept plus corticosteroids or B placebo plus corticosteroids Patients will receive a total of eight doses of etanercept or placebo over a 4-week period The initial dose of etanercept or placebo will be administered intravenously on Day 0 with subsequent doses administered subcutaneously SQ Dosing will be administered twice weekly over 4 consecutive weeks The placebo will be the inert diluent used for the etanercept formulation
Additionally patients in both arms will receive corticosteroids 2 mgkgday Day 0 through Day 7 with subsequent taper as clinically indicated Chest radiographs shall be obtained weekly through Day 28 Plasma cytokine profiles will be obtained on Days 0 7 and 28
For patients 30 days post-transplant If the patients clinical condition is such that a broncho-alveolar lavage BAL is deemed not possible to be performed by the treating physician or pulmonologist then the on study BAL may be waived In such circumstances the patient may register and be randomized to study therapy without the BAL being undertaken
For patients not on mechanical ventilation If a BAL is not done appropriate virology studies on a nasal swab or nasal washing are required as a minimum procedure to study entry
For patients on mechanical ventilation Microbiologic studies of a deep endotracheal aspirate are allowed in lieu of a formal bronchoscopy procedure However no protocol-specified biologic studies see Section 44 will be done on these specimens
For patients 31-180 days post-transplant An on study bronchoscopy is required in all cases
If at any point following initiation of study drug therapy previously obtained BAL fluid cultures or other BAL fluid analysis become positive for an infectious pathogen study drug therapy shall be discontinued at that point and not re-instituted The patient will discontinue study drug therapy but will still be followed for outcome
The primary study endpoint is response at Day 28 Patients who discontinue study drug therapy for any reason will still be followed for primary and secondary study endpoints
Over the last two decades allogeneic hematopoietic cell transplantation HCT has emerged as an important treatment for a number of malignant and non-malignant disorders Unfortunately several complications including graft-versus-host disease GVHD and pulmonary dysfunction limit the utility of this aggressive form of therapy Infectious and non-infectious lung complications occur in 25 to 55 of HCT recipients and account for up to 50 of transplant-related mortality In about half of affected patients no infectious organisms are identified in the lungs Two major types of non-infectious pulmonary injury are recognized acute idiopathic pneumonia syndrome IPS and sub-acute lung injury obstructive airway disease or bronchiolitis obliterans BrOb and restrictive lung disease The current study will examine the use of etanercept in patients with IPS
DESIGN NARRATIVE
Eligible patients will be randomized to receive one of two arms of therapy A etanercept plus corticosteroids or B placebo plus corticosteroids Patients will receive a total of eight doses of etanercept or placebo over a 4-week period The initial dose of etanercept or placebo will be administered intravenously on Day 0 with subsequent doses administered subcutaneously SQ Dosing will be administered twice weekly over 4 consecutive weeks The placebo will be the inert diluent used for the etanercept formulation
Additionally patients in both arms will receive corticosteroids 2 mgkgday Day 0 through Day 7 with subsequent taper as clinically indicated Chest radiographs shall be obtained weekly through Day 28 Plasma cytokine profiles will be obtained on Days 0 7 and 28
For patients 30 days post-transplant If the patients clinical condition is such that a broncho-alveolar lavage BAL is deemed not possible to be performed by the treating physician or pulmonologist then the on study BAL may be waived In such circumstances the patient may register and be randomized to study therapy without the BAL being undertaken
For patients not on mechanical ventilation If a BAL is not done appropriate virology studies on a nasal swab or nasal washing are required as a minimum procedure to study entry
For patients on mechanical ventilation Microbiologic studies of a deep endotracheal aspirate are allowed in lieu of a formal bronchoscopy procedure However no protocol-specified biologic studies see Section 44 will be done on these specimens
For patients 31-180 days post-transplant An on study bronchoscopy is required in all cases
If at any point following initiation of study drug therapy previously obtained BAL fluid cultures or other BAL fluid analysis become positive for an infectious pathogen study drug therapy shall be discontinued at that point and not re-instituted The patient will discontinue study drug therapy but will still be followed for outcome
The primary study endpoint is response at Day 28 Patients who discontinue study drug therapy for any reason will still be followed for primary and secondary study endpoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMTCTN0403 | OTHER | None | None |
| U01HL069294-05 | NIH | None | None |
| 465 | OTHER | BMT CTN | httpsreporternihgovquickSearchU01HL069294-05 |