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.
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 post-treatment. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Given PO
Given PO
M D Anderson Cancer Center
Houston, Texas, United States
Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib
Number of participants who develop DLT's after the administration of the study drug
Time frame: Up to 6 months
Treatment failure
Defined as a decrease in the absolute value of % forced expiratory volume in 1 second (FEV1) by 10% or more.
Time frame: At 3 and 6 months
Changes in National Institutes of Health (NIH) symptom-based lung score
Improvement in NIH symptom-based lung score; Score 0 (no symptoms), Score 1 (shortness of breath with stairs), Score 2 (shortness of breath on flat ground), and Score 3 (shortness of breath at rest or requiring oxygen
Time frame: At 3 and 6 months
Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies
Will include the St. George's Respiratory Questionnaire (SGRQ Regression models will include time, and different covariance structures will be included, including unstructured and autoregressive integrated moving average (ARIMA). The analysis will be adjusted for potential confounding variables. Participants will answer a St. George's Respiratory Questionnaire. (Very Poor, Poor, Fair, Good, Very Good)?
Time frame: Baseline and at 3 and 6 months
Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies
Will include the Lee chronic GVHD symptom scale Lee symptom scale. Regression models will include time, and different covariance structures will be included, including unstructured and autoregressive integrated moving average (ARIMA). The analysis will be adjusted for potential confounding variables. The Lee Chronic GVHD Symptom Scale is a 30 item instrument with 7 subscales (skin, eyes, mouth, lung, nutrition, energy and psych) containing 2-7 items. Response options range from 0-4 (0-Not at all, 1-Slightly, 2-Moderately, 3-Quite a bit, 4-Extremely).
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Time frame: Baseline up to 6 months
Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies
Will include the study Short Form 36 (SF-36), NIH lung symptom score and SF-36 due to the longitudinal nature of the observations. Regression models will include time, and different covariance structures will be included, including unstructured and autoregressive integrated moving average (ARIMA). The analysis will be adjusted for potential confounding variables.
Time frame: Baseline and at 3 and 6 months
Change in 6-minute walk test
Time frame: Baseline and at 3 and 6 months
Failure-free survival
Will be assessed and monitored
Time frame: At 6 months
Non-relapse mortality
Defined as the absence of need for additional line treatment, non-relapse mortality and recurrent malignancy.
Time frame: At 6 months
Overall survival
Will be assessed and monitored
Time frame: At 6 months