A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant … (NCT04107675) | Clinical Trial Compass
TerminatedPhase 2
A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4)
Stopped: Due to the low number of patients recruited and the slow enrollment pace of patients, on 18 March 2022, the sponsor decided to terminate the BOSTON-4 safety and tolerability trial ahead of time.
France6 participantsStarted 2020-02-11
Plain-language summary
Primary Objective:
The primary objective of this study is to assess the tolerability and safety of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients.
Secondary Objectives:
The secondary objectives of this study are to assess PK and exploratory efficacy and quality of life of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \>/= 18 years
✓. Patient must have a history of allogeneic HSCT, regardless of source of stem cell or donor or indication for allogeneic HSCT
✓. Documented diagnosis of chronic Graft versus Host Disease (cGvHD) in any organ other than the lung. If BOS is the only manifestation of cGvHD, lung biopsy must have been performed before entering the trial to confirm BOS diagnosis.
✓. Confirmed diagnosis of BOS Score 1 \[Jagasia et al. 2015\] within \> 6 months and \< 3 years after allo-HSCT:
✓. Patient must be capable of understanding the purposes and risks of the study, has given written informed consent, and agrees to comply with the study requirements.
✓. Patient is capable of aerosol inhalation.
✓. Women of childbearing potential must have a negative serum or urine pregnancy test at screening and at randomization visit.
Exclusion criteria
✕. Active bacterial, viral (as confirmed by multiplex PCR) or fungal infection not successfully resolved at least 4 weeks prior to the Screening Visit.
What they're measuring
1
Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4)
Timeframe: at Week 4 (visit 3)
2
Number of Participants With AE and sAE of Different Level of Severity During the First 4 Weeks of Treatment
✕. Chronic renal dysfunction with serum creatinine \>/= 2.5 mg/dL or need for renal dialysis.
✕. Chronic hepatic dysfunction with serum total bilirubin \> 5x upper limit of normal (ULN), transaminases \> 5x ULN, or alkaline phosphatase \> 5x ULN.
✕. Evidence of relapse of the primary malignancy which warranted allogeneic bone marrow transplant.
✕. Use of azithromycin within 4 weeks prior to Randomization (Visit 1).
✕. Use of zafirlukast during the study period.
✕. Chronic oxygen use or use of non-invasive ventilation.
✕. Active smokers (i.e. any kind of inhaled nicotine consumption).