Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell … (NCT04239989) | Clinical Trial Compass
TerminatedPhase 1
Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant
Stopped: \<75% participation
United States8 participantsStarted 2021-10-08
Plain-language summary
This phase I trial studies how well itacitinib works for the treatment of bronchiolitis obliterans syndrome after donor hematopoietic cell transplant. Itacitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. BOS diagnosed within the past 6 months of enrollment, defined by 2015 National Institutes of Health (NIH) Consensus Criteria 126
✓. The ability to understand and sign a written informed consent form
✓. Contraception for women and men of child bearing potential. Permitted methods should be at least 99% effective in preventing pregnancy.
✓. Male patients must be willing to refrain from donating sperm during their participation in the study and for at least 3 months after completing the study.
Exclusion criteria
✕. Prior treatment with any other JAK inhibitor (including Ruxolitinib) for BOS or any other indication within the past 6 months of enrolment.
✕. Patients on mechanical ventilation or resting by pulse oximetry O2 saturation \<88%
✕. FEV1 \<40% predicted
✕. Relapsed primary malignancy for which SCT was performed
✕. History of progressive multifocal leuko-encephalopathy (PML)
What they're measuring
1
Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib