Malignant Hematological Diseases Clinical Trial
Official title:
Evaluation of the Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05929092 -
TFBC Combined With UCBT in the Treatment of High-risk Malignant Hematological Diseases
|
N/A |