Status:
RECRUITING
Ruxolitinib for Early Lung Dysfunction After Hematopoietic Stem Cell Transplant
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Hematopoietic Stem Cell Transplant (HSCT)
Bronchiolitis Obliterans (BO)
Eligibility:
All Genders
5-60 years
Phase:
PHASE2
Brief Summary
Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy, and lung injury affects as many as 25% of children receiving HSCT. Improved transplant techniques and major improvements in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04908735
Start Date
November 12 2021
End Date
November 1 2028
Last Update
December 16 2025
Active Locations (3)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104