Itacitinib for the Prevention of Graft Versus Host Disease

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Incyte Corporation
• Treatments: Busulfan; Cyclophosphamide; Fludarabine; Tacrolimus; Thiotepa

Criteria

Inclusion Criteria:

• Patients 18 years to less than or equal to 70 years

• 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

• Human leukocyte antigen (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)

• Intrauterine device (IUD)

• Birth control injections

• Double barrier methods (diaphragm with spermicidal gel or condoms with birth control foam)

• Sterilization of patient or partner ("tubes tied" or vasectomy)

Exclusion Criteria:

• Patients with toxicities (Grade > 1) unresolved from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery)

• Active or clinically significant cardiac disease including:

• Congestive heart failure - New York Heart Association (NYHA) > class II

• Active coronary artery disease

• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin

• Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before transplant, or myocardial infarction within 6 months before transplant

• Patients with active hepatitis B and C