Itacitinib for the Prevention of Graft Versus Host Disease (NCT04859946) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Itacitinib for the Prevention of Graft Versus Host Disease
United States31 participantsStarted 2022-01-11
Plain-language summary
This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. An allogeneic transplant uses blood-making cells from a family member or unrelated donor to remove and replace a patient's abnormal blood cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Giving itacitinib with standard of care treatment after the transplant may stop this from happening.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients 18 years to less than or equal to 70 years
* English and non-English speaking patients are eligible
* Karnofsky performance status of at least 70
* Patients with hematological disorders undergoing allogeneic stem cell transplant (ASCT) with conditioning regimen of fractionated busulfan, thiotepa and fludarabine
* Donor will be matched at HLA A, B, C and DR at allele level. Donor will be either HLA-identical sibling or at least 7/8 matched unrelated donor, or a haploidentical related donor available.
* Life expectancy of at least 12 weeks (3 months)
* Direct bilirubin not greater than 1 mg/dL
* Alanine transaminase (ALT) less than or equal 3 x upper limit of normal range
* Creatinine clearance \>/= 60 ml/ min
* Diffusing capacity for carbon monoxide (DLCO) 50% of predicted corrected for hemoglobin
* Left ventricular ejection fraction (LVEF) of at least 50%
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
* Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 30 days after the last dose of study drug. Recommended methods of birth control are:
* Hormonal contraception (birth control pills, patches, or rings)
…
What they're measuring
1
Incidence of acute grade 2-4 graft versus host disease (GVHD)