This phase I trial studies the effect of itacitinib in treating patients with 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04239989.
PRIMARY OBJECTIVE:
I. To assess the safety of itacitinib in patients with bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic cell transplantation (HCT).
SECONDARY OBJECTIVES:
I. To assess treatment failure at 3 months and 6 months.
II. To assess change in symptom-based lung score at 3 months and 6 months.
III. To assess change in the St. George Respiratory Questionnaire and Study Short Form 36 at 3 months and 6 months.
IV. To assess change in the Lee chronic graft versus host disease (GVHD) symptom scale at 3 months and 6 months.
V. To assess change in 6-minute walk test at 3 months and 6 months.
VI. To assess failure-free survival at 6 months.
VII. To assess non-relapse mortality at 6 months.
VIII. To assess overall survival at 6 months.
OUTLINE:
Patents receive itacitinib orally (PO) once daily (QD) for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up for 30 days.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorAmin Majid Alousi
