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Neutrophil Elastase Inhibitor

Alvelestat for Bronchiolitis Obliterans Syndrome

Phase 1 & 2

Recruiting

Led By Steven Z Pavletic, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Received prior treatment with specific regimen for at least 3 months prior to enrollment

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase 1b: baseline, 8 wees. phase 2: baseline, 3 months and 6 months (end of treatment).

Awards & highlights

Study Summary

This trial is testing a new drug, alvelestat (MPH966), to see if it's safe and effective in treating bronchiolitis obliterans syndrome (BOS). BOS is a complication people can experience after hematopoietic stem cell transplant.

Who is the study for?

Adults over 18 who've had a stem cell transplant and suffer from chronic graft versus host disease (cGVHD) with Bronchiolitis Obliterans Syndrome (BOS). They must have been treated for cGVHD, have certain lung function test results, stable organ/marrow function, and agree to contraception. Excluded are those with recent malignancy treatments, uncontrolled illnesses, pregnancy/breastfeeding, prior neutrophil elastase inhibitors use or significant alcohol consumption.Check my eligibility

What is being tested?

The trial is testing alvelestat (MPH966), which may inhibit neutrophil elastase that's thought to contribute to BOS after stem cell transplants. It involves two parts: varying doses over cycles up to 4 months followed by the best dose for up to a year. Participants will undergo extensive monitoring including lung/heart tests and bronchoscopy.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of alvelestat could include typical drug reactions such as digestive issues, liver problems given its exclusion criteria related to liver health; heart complications considering ECG requirements; and possibly respiratory symptoms due to its focus on lung conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a specific treatment for at least 3 months before joining.

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I am 18 years old or older.

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I have been diagnosed with BOS based on specific criteria.

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I can care for myself but may need occasional help.

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I have had a stem cell transplant and suffer from moderate to severe chronic GVHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase 1b: baseline, 8 wees. phase 2: baseline, 3 months and 6 months (end of treatment).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~phase 1b: baseline, 8 wees. phase 2: baseline, 3 months and 6 months (end of treatment).

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 1b: baseline, 8 wees. phase 2: baseline, 3 months and 6 months (end of treatment). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

determine the safety of MPH966

Secondary outcome measures

Phase 1B and 2: Determine effect on patient-reported outcomes viaLee cGVHD Symptom Scale, HAP, FACT-BMT

Phase 1B and 2: Determine the impact on lung inflammatory markers based on levels in blood, sputum and BAL fluid

Phase 1B: Correlation of NE activity in blood with sputum measurements

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment1 Intervention

MTD po bid on days 1-28

Group II: Phase 1bExperimental Treatment1 Intervention

Phase Ib dose escalation

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,667 Previous Clinical Trials

40,926,098 Total Patients Enrolled

30 Trials studying Bronchiolitis Obliterans Syndrome

3,583 Patients Enrolled for Bronchiolitis Obliterans Syndrome

Steven Z Pavletic, M.D.Principal InvestigatorNational Cancer Institute (NCI)

15 Previous Clinical Trials

3,769 Total Patients Enrolled

4 Trials studying Bronchiolitis Obliterans Syndrome

764 Patients Enrolled for Bronchiolitis Obliterans Syndrome

Media Library

MPH966 (Neutrophil Elastase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02669251 — Phase 1 & 2

Bronchiolitis Obliterans Syndrome Research Study Groups: Phase 1b, Phase 2

Bronchiolitis Obliterans Syndrome Clinical Trial 2023: MPH966 Highlights & Side Effects. Trial Name: NCT02669251 — Phase 1 & 2

MPH966 (Neutrophil Elastase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02669251 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients being accepted into this trial at this time?

"Yes, the clinicaltrials.gov website currently has this trial listed as recruiting patients. This study was first posted on April 28th, 2016 and updated on November 11th, 20202. 34 people are needed to participate at 2 different sites."

Answered by AI

What is the desired outcome of this research?

"The primary outcome of this clinical trial is to determine the safety of MPH966, which will be monitored over a period of six months. Secondary outcomes includePhase 1B and 2: Determine effect on patient-reported outcomes via Lee cGVHD Symptom Scale, HAP, FACT-BMT; Phase 2: Efficacy testing via NIH Lung Symptom Score, 6 minute walk test, survival, FEV1 slope measured from baseline, and other PFT measurements; and Phase 2: Determine effect on markers of target inhibition in sputum and blood."

Answered by AI

If I am below the age of seventy, can I still participate in this research?

"The age range for this clinical trial is much larger than most, as it includes people aged 18 to 99. There are 471 other trials available for minors and 1188 different trials available for senior citizens."

Answered by AI

How many people are included in this clinical research project?

"Yes, this is an ongoing clinical trial that was first posted on April 28th, 2016. As of the most recent update on November 11th, 2022, the study is looking for 34 participants at 2 sites."

Answered by AI

Could I be a potential candidate for this research?

"Up to 34 patients that suffer from the target disease and are aged 18 or 99 can be admitted into this clinical trial. The most crucial requirements for participants are as follows: FEV1 must be less than 75% of the predicted value, with a decline of 10% or more over 2 years; this percentage should not increase to higher than 75% when albuterol is used, and the absolute decline in value should still remain at 10% or greater from the pre-transplant baseline. For Phase 1b study patients, they may have received a BOS diagnosis at any point in time. As for Phase 2 study patients,"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02669251.

All > Graft Vs Host Disease