Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT04908735
Eligibility Criteria:
Inclusion Criteria:
Subjects ≥ 5 years and ≤ 60 years of age who have undergone allogeneic HCT AND exhibit early lung dysfunction as defined by any one of the following:
* \>10% decrease in FEV1 from baseline or decrease of 25% of FEF 25-75 from baseline
* active GVHD in another organ system + pulmonary symptoms (Tachypnea without wheezing, new oxygen requirement, cough)
* Increased R5 by 50% by clinical oscillometry
* Air trapping on CT, small airway thickening, or bronchiectasis
AND - All age groups, including adults:
Adequate renal function defined as estimated Creatinine Clearance (CrCl) ≥ 30 mL/min as calculated by the cystatin c GFR or nuclear GFR
Adequate hepatic function as defined by:
* ALT and AST ≤ 5 x ULN, unless the ALT / AST increase is due to cGVHD
* Total bilirubin of ≤ 5 x ULN (unless of non-hepatic origin or due to Gilbert's Syndrome) or Total bilirubin of \< 10 x ULN if due to GVHD
Adequate hematological function defined as:
* Absolute neutrophil count ≥1.0 x 10\^9/L
* Platelets ≥30 x 10\^9/L
PT/INR \<2 x ULN and PTT (aPTT) \< 2 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)
Exclusion Criteria:
* Known hypersensitivity to any constituent of the study medication.
* Active uncontrolled pulmonary infection (preceding infectious evaluation including bronchoscopy as clinically indicated)
* Subjects who are pregnant or breastfeeding or are at risk of pregnancy or fathering a baby and are unable to use acceptable highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices \[IUDs\], complete abstinence or sterilized partner) and a barrier method (e.g., condoms, cervical ring, sponge, etc.) during the period of therapy and for 90 days for both females and males after the last dose of study drug.
* Subjects previously treated with investigational agent for GVHD within the 30 days prior to first dose of study treatment. Other non-GVHD additional investigational agents may be allowed on a case by case basis with review/approval by the study Lead PI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
60 Years
Study:
NCT04908735
Study Brief:
Protocol Section:
NCT04908735