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

NCT00141726 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 3-31IRBMED 2003-0590 and HUM 46747
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Injury, Acute; Respiratory Distress Syndrome, Adult; Bronchiolitis Obliterans

Keywords

Enbrel; Stem Cell Transplantation; Lung Injury

Outcome Measures

Primary Outcomes (1)

• Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO

  Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .

  week 12 post therapy

Secondary Outcomes (1)

• Percentage of Participants That Experience Grade 3 to 4 Adverse Events

  continuously (and week 4, week 8 and week 12, week 20)

Study Arms (1)

etanercept treatment

EXPERIMENTAL

Etanercept for lung injury

Drug: Etanercept

Interventions

Etanercept DRUG

Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.

Also known as: Enbrel

etanercept treatment

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Yanik GA, Mineishi S, Levine JE, Kitko CL, White ES, Vander Lugt MT, Harris AC, Braun T, Cooke KR. Soluble tumor necrosis factor receptor: enbrel (etanercept) for subacute pulmonary dysfunction following allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2012 Jul;18(7):1044-54. doi: 10.1016/j.bbmt.2011.11.031. Epub 2011 Dec 10.

  PMID: 22155140 RESULT

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome; Bronchiolitis Obliterans; Lung Injury

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Gregory Yanik, M.D.
• Organization: University of Michgan Comprehensive Cancer Center

gyanik@umich.edu

734-936-8785

Study Officials

• Gregory A Yanik, MD

  The University of Michigan Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: October 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: February 1, 2009
• Last Updated: December 3, 2015
• Results First Posted: June 19, 2014

Record last verified: 2015-11

Locations

US (1)