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

NCT02669251 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Chronic Graft vs Host Disease
  • Chronic Graft-Versus-Host Disease
  • Bronchiolitis Obliterans Syndrome

Interventions

DRUG

MPH966

Phase 1b Cycle= 14 days: Each dose level will increase by 60mg PO BID, up to a maximum of 240mg PO BID Phase 2 Cycle=28 days: MTD PO BID

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Najla El Jurdi, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-28
Primary Completion
2027-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02669251 on ClinicalTrials.gov