Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2022-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The occurrence of bronchiolitis obliterans syndrome (SBO) after allogeneic hematopoietic stem cell transplantation (HSCT) is considered to be a chronic pulmonary graft versus host disease (GVHD) that is associated with significant mortality and morbidity. The reported incidence of SBO varies from 6 to 26% of allogeneic HSC recipients and is usually diagnosed within 2 years after transplantation. The diagnosis of SBO relies on the occurrence of a new airflow obstruction identified during pulmonary function testing, and the definition differs between studies. Currently, no curative immunosuppressive treatment is available, and recent data suggest that the use of these treatments, especially corticosteroids, should be limited because of their toxicity. The impairment of lung function parameters is likely caused by fibrous small airway lesions. Few data on the pathogenesis of SBO after allogeneic HSCT are available. Several hypotheses are based on the occurrence of SBO during chronic graft rejection after lung transplantation, which shares many clinical and histopathological similarities with SBO after allogeneic HSCT. One hypothesis is that the first step leading to SBO is lung epithelium injury. SBO is then identified as an alloimmune reaction with only one clearly identified risk factor: extrathoracic chronic GVHD. Due to their anti-inflammatory and immunomodulatory properties, recent data suggest that low-dose macrolides may be effective at preventing SBO after lung transplants. This well-tolerated treatment may be useful for preventing SBO after allogeneic HSCT.

The objective of this Phase 3 multicentre randomized, double-blinded, clinical trial is to evaluate the efficacy of azithromycin in preventing BO syndrome after allogeneic HSCT in patients with malignant hematological diseases.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation

NCT03072849

Bronchiolitis Obliterans Syndrome

COMPLETED

Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant

NCT01432080

Respiratory Tract Infections Bronchiolitis Obliterans Cryptogenic Organizing Pneumonia +1 more

TERMINATED PHASE2

Allo HSCT Using RIC and PTCy for Hematological Diseases

NCT05805605

Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Biphenotypic Acute Leukemia +15 more

RECRUITING PHASE2

High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of GVHD

NCT05895201

Bone Marrow Transplant Complications Acute Myeloid Leukemia Acute Lymphoblastic Leukemia, Adult +2 more

WITHDRAWN PHASE1/PHASE2

Pilot Study of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation for Pediatric Hematopoietic Malignancies

NCT00013533

Hodgkin Lymphoma Lymphocytic Leukemia Mixed Cell Leukemia +6 more

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Hematological Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Azithromycine

250 mg x 3/week during a meal for a period of 2 years

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

250 mg x 3/week per os during a meal for a period of 2 years

Placebo

250 mg x 3/week during a meal for a period of 2 years.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

250 mg x 3/week during a meal for a period of 2 years

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Azithromycin

250 mg x 3/week per os during a meal for a period of 2 years

Intervention Type DRUG

Placebo

250 mg x 3/week during a meal for a period of 2 years

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients\> 16 years old
* Experimenting an allogeneic HSCT for a hematologic malignancy
* Pre-transplantation Pulmonary Function Testing
* With written informed consent

Exclusion Criteria

* Allergy or Intolerance to azithromycin, macrolides or ketolide or excipient
* Prolonged corrected QT (QTc) interval (\>450 msec)
* Taking medications that prolong the QTc interval (Cisapride, ergotamine, dyhydroergotamine)
* Taking ergotamine and dyhydroergotamine due to the risk of ergotism
* Family history of a prolonged QTc interval.
* History of congestive heart failure
* Taking colchicine Severe liver insufficiency • History of infection due to atypical mycobacteria

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No