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NCT02669251 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Chronic Graft Versus Host Disease and Bronchiolitis Obliterans Syndrome, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
14
Enrollment target
1
Study location

NCT02669251 is a Phase 1 study of Chronic Graft Versus Host Disease and Bronchiolitis Obliterans Syndrome that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 116-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02669251, a Phase 1 study of Chronic Graft Versus Host Disease and Bronchiolitis Obliterans Syndrome, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
14 participants
Enrollment target
1
Study location

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 Studied

Chronic Graft Versus Host Disease Bronchiolitis Obliterans Syndrome Chronic Graft vs. Host Disease

Interventions

  • DRUG MPH966

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2016-04-28
Est. Completion 2027-12-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT02669251

The ClinicalTrials.gov registry entry for NCT02669251 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (88% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 1 intervention - of which MPH966 is the first listed.

NCT02669251 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT02669251 about?

NCT02669251 is a clinical study titled "Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation". 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 red...

What is the current status of trial NCT02669251?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-04-28. Estimated completion is 2027-12-01.

What conditions does trial NCT02669251 study?

This clinical trial studies the following conditions: Chronic Graft Versus Host Disease, Bronchiolitis Obliterans Syndrome, Chronic Graft vs. Host Disease.

What interventions are being tested in trial NCT02669251?

The interventions under investigation include: MPH966 (DRUG).

Who is sponsoring clinical trial NCT02669251?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02669251 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.