RECRUITING

Upfront Ruxolitinib for Chronic Graft-vs-host Disease

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Conditions

Chronic Graft Versus Host Disease

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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

While hematopoietic stem cell transplant (HSCT) is an effective therapy, graft versus host disease (GVHD) is the most significant complication after HSCT. Corticosteroids (or steroids) have been the mainstay of treatment for chronic GVHD for many decades now. Increasingly, newer immunosuppressive and immunomodulating agents are being studied in adults and children affected by cGVHD. Ruxolitinib is one of these promising newer agents, which has been shown to be effective in the treatment of cGVHD in both children and adults. Currently, ruxolitinib is generally added to a patient's treatment regimen after (or with) a course of high dose steroids. The purpose of this study is to examine the effectiveness of upfront single agent ruxolitinib for cGVHD.

Official Title

Upfront Ruxolitinib Treatment for Chronic Graft-vs-host Disease in Children and Young Adults: A Corticosteroid-sparing Pilot Study

Quick Facts

Study Start:2024-12
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06695507

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:12 Years to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newly diagnosed moderate to severe chronic graft versus host disease (as defined by NIH cGVHD consensus criteria), requiring systemic treatment
  2. * Patient aged ≥12 year-old and ≤30 year-old
  3. * Patient able to take oral or enteral medication
  4. * No active, clinically significant uncontrolled infections
  5. * ALT ≤ 5x upper limit of normal (ULN) and total bilirubin ≤ 5xULN (unless presumed liver GVHD)
  6. * Platelet ≥ 20k and ANC ≥ 500. The use of transfusions or growth factors is permitted to maintain counts at these thresholds
  7. * No prior systemic treatment for chronic GVHD. Patients previously treated for acute GVHD are eligible, including those who received ruxolitinib for treatment of their aGVHD
  8. * Patients must be on ≤ physiologic dosing (i.e. hydrocortisone 8-12mg/m2/day) at enrollment
  9. * Patients with prior acute GVHD on \< 1 mg/kg steroids with new onset moderate-severe chronic GVHD may be considered for enrollment if they can taper steroids to reach physiological hydrocortisone in 1 month. If unable to do so these patients will come off study and be replaced
  1. * Mild cGVHD (as defined by NIH cGVHD consensus criteria11), that does not require systemic therapy
  2. * Acute or late acute GVHD without any evidence of chronic GVHD features
  3. * Patients who have received corticosteroids for ≥ 24 hours at 1 mg/kg/day of methylprednisolone or prednisone with the intent to treat cGVHD at time of enrollment
  4. * Corticosteroid dosing above physiologic dose hydrocortisone (i.e. \> 8-12mg/m2/day) at time of enrollment
  5. * Clinical evidence suggesting active malignancy (including PTLD and primary/secondary malignancy)
  6. * Clinical evidence of clinically significant active infection
  7. * Ongoing cytopenias which cannot be supported with routine supportive care (keeping hemoglobin over 7 g/dL and platelets \>20,000 and absolute neutrophil count over 500/uL)
  8. * Active lower gastrointestinal bleeding
  9. * Thrombosis within 6 months (including myocardial infarction, stroke, deep venous thrombosis, pulmonary embolism). IV infiltration will not be included as an example of thrombosis
  10. * Pregnant or lactating females; patients of childbearing age who are not able to comply with contraceptive recommendations
  11. * Other condition that PI feels would preclude the patient from complying with study activities
  12. * ESRD \[CLcr \< 15 mL/min\] not on dialysis
  13. * Overlap syndrome

Contacts and Locations

Study Contact

Claire Dusa
CONTACT
(513) 803-4541
Claire.Dusa@cchmc.org

Principal Investigator

Pooja Khandelwal, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Pooja Khandelwal, 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 Date2024-12
Study Completion Date2028-06

Study Record Updates

Study Start Date2024-12
Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Graft Versus Host Disease