RECRUITING

Ruxolitinib for Early Lung Dysfunction After Hematopoietic Stem Cell Transplant

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Conditions

Hematopoietic Stem Cell Transplant (HSCT)Bronchiolitis Obliterans (BO)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 survival mean that HSCT is being more widely used, and more mismatched grafts are being used. Bronchiolitis obliterans (BO) is a major limitation of pediatric HSCT success as BO is commonly diagnosed late in children, when lung injury is irreversible, leading to long term morbidity or even death. Currently, there are major gaps in our knowledge regarding incidence, etiology and optimal treatment of BO following HSCT, and important diagnostic limitations specific to children. Diagnosis of BO is usually based on performance of pulmonary function tests, which is usually impossible in ill children under 10. Even older children who feel unwell or un-cooperative may be unable to produce interpretable data. These deficiencies in diagnosis mean that BO is commonly diagnosed late, meaning fibrosis has occurred and lesions are irreversible. The hypothesis for this interventional trial is that early treatment with standard Flovent/montelukast and steroids plus ruxolitinib will reverse lung injury and reduce the frequency of chronic pulmonary impairment or florid BO.

Official Title

Ruxolitinib for Early Lung Dysfunction After HSCT: a Phase II Study

Quick Facts

Study Start:2021-11-12
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04908735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>10% decrease in FEV1 from baseline or decrease of 25% of FEF 25-75 from baseline
  2. * active GVHD in another organ system + pulmonary symptoms (Tachypnea without wheezing, new oxygen requirement, cough)
  3. * Increased R5 by 50% by clinical oscillometry
  4. * Air trapping on CT, small airway thickening, or bronchiectasis
  5. * ALT and AST ≤ 5 x ULN, unless the ALT / AST increase is due to cGVHD
  6. * 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
  7. * Absolute neutrophil count ≥1.0 x 10\^9/L
  8. * Platelets ≥30 x 10\^9/L
  1. * Known hypersensitivity to any constituent of the study medication.
  2. * Active uncontrolled pulmonary infection (preceding infectious evaluation including bronchoscopy as clinically indicated)
  3. * 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.
  4. * 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.

Contacts and Locations

Study Contact

Sara Loveless, BSN, RN
CONTACT
(513) 803-7656
Sara.Loveless@cchmc.org
Evelyn Nguyen, MS
CONTACT
(513) 636-4379
Evelyn.Nguyen@cchmc.org

Principal Investigator

Kasiani Myers, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Kasiani Myers, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-12
Study Completion Date2025-11

Study Record Updates

Study Start Date2021-11-12
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic Stem Cell Transplant (HSCT)
  • Bronchiolitis Obliterans (BO)