Status:
COMPLETED
Itacitinib for Low Risk GVHD
Lead Sponsor:
John Levine
Conditions:
Low Risk Acute Graft-versus-host Disease
Graft-versus-host-disease
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
Brief Summary
Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can lead to serious complications. A new blood test can identify patients whose GVHD is most likely to respond to...
Detailed Description
Patients with newly diagnosed low risk acute GVHD defined as Minnesota standard risk based on symptoms and Ann Arbor 1 GVHD based on biomarkers were eligible if they met all other eligible criteria (s...
Eligibility Criteria
Inclusion
- Newly diagnosed GVHD that meets criteria for Minnesota standard risk
- Ann Arbor 1 GVHD by biomarkers
- GVHD not previously treated systemically (topical therapies and non-absorbed steroids are allowed)
- Any donor type, HLA-match, conditioning regimen is acceptable
- Age 12 - 75 years (children \<18 years must also weigh 50 kg or more)
- Patients must be engrafted post-transplant (ANC \>500/μL and platelet count \>20,000). Use of growth factor supplementation to maintain neutrophil count is allowed.
- Direct bilirubin must be \<2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.
- ALT/SGPT and AST/SGOT must be \<5x the upper limit of the normal range within 3 days prior to enrollment.
- Signed and dated written informed consent obtained from patient or legal representative.
Exclusion
- Patients currently being treated with any JAK inhibitor including ruxolitinib
- Relapsed, progressing, or persistent malignancy requiring withdrawal of systemic immune suppression
- Patients with uncontrolled infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
- Severe organ dysfunction including requirement for dialysis, mechanical ventilation or oxygen supplementation exceeding 40% FiO2 within 7 days of enrollment.
- Creatinine clearance or estimated glomerular filtration rate \<30 ml/min as calculated by institutional practice (e.g., Cockcroft-Gault equation, CKD-EPI equation, etc)
- A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
- Patients receiving corticosteroids \>10 mg/day prednisone (or other steroid equivalent) for any indication within 7 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions/IV meds
- Patients who are pregnant
- Patients receiving investigational agents within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of itacitinib
- History of allergic reaction to itacitinib or any JAK inhibitor
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03846479
Start Date
March 25 2019
End Date
May 11 2022
Last Update
February 6 2023
Active Locations (14)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
3
Emory University
Atlanta, Georgia, United States, 30003
4
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322