Active — Not RecruitingPhase 1/2

Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation

United States14 participantsStarted 2016-04-28

Plain-language summary

Background: Bronchiolitis obliterans syndrome (BOS) is a complication people can experience after hematopoietic stem cell transplant. It usually affects people with chronic graft versus host disease (cGVHD). This occurs when donor stem cells attack the cells of the person who received them. BOS reduces airflow and oxygen levels in the body. It may be caused by neutrophil elastase in the body. Researchers believe the new drug alvelestat (MPH966) may help. Objectives: To test the safety of alvelestat (MPH966) and see what dose best inhibits neutrophil elastase in people with BOS after a stem cell transplant. To study how well the best dose improves lung function in those people. Eligibility: Adults 18 and older who have had a hematopoietic stem cell transplant and have cGVHD and BOS. Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. They will have lung function and heart function tests. They will have computed tomography scans of the chest. Study part 1: Participants will take the starting dose of the study drug by mouth twice a day for 14 days. This is 1 cycle. They will get different doses, for up to 4 cycles. Study part 2: Participants will take the study drug twice a day by mouth at the dose set in part 1, for up to 12 months. Participants will keep medicine diaries. Participants will have several study visits. These may include: Repeats of the screening tests. Bronchoscopy with bronchoalveolar lavage. Sputum samples taken. 6-minute walking test. cGVHD assessment and answer questions. Participants will be contacted after the study for up to 24 months.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution CT, or
✓. Evidence of air trapping by PFTs: residual volume \>120% predicted or residual volume/total lung capacity elevated outside the 90% confidence interval.
✓. Evidence of air trapping by expiratory CT
✓. small airway thickening or bronchiectasis by high-resolution CT
✓. Evidence of air trapping by PFTs: residual volume \>120% predicted or residual volume/total lung capacity elevated outside the 90% confidence interval.
✓Ability of subject to understand and the willingness to sign a written informed consent document.

What they're measuring

Optimal biologic dose (OBD) based on maximal NE inhibition measured in sputum

Timeframe: 8 weeks after study drug initiation

To determine the clinical efficacy of MPH966 at the OBD in patients with BOS after SCT

Timeframe: 6 months

determine the safety of MPH966

Timeframe: 8 weeks after study drug initiation

Trial details

NCT IDNCT02669251

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-12-01

View on ClinicalTrials.gov More Chronic Graft vs Host Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution CT, or
✓. Evidence of air trapping by PFTs: residual volume \>120% predicted or residual volume/total lung capacity elevated outside the 90% confidence interval.
✓. Evidence of air trapping by expiratory CT
✓. small airway thickening or bronchiectasis by high-resolution CT
✓. Evidence of air trapping by PFTs: residual volume \>120% predicted or residual volume/total lung capacity elevated outside the 90% confidence interval.
✓Ability of subject to understand and the willingness to sign a written informed consent document.

What they're measuring

Optimal biologic dose (OBD) based on maximal NE inhibition measured in sputum

Timeframe: 8 weeks after study drug initiation

To determine the clinical efficacy of MPH966 at the OBD in patients with BOS after SCT

Timeframe: 6 months

determine the safety of MPH966

Timeframe: 8 weeks after study drug initiation