Itacitinib for the Prevention of Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplantation

• Status: Withdrawn
• Trial end date: 2020-09-22
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well itacitinib works in preventing graft versus host disease in patients with blood disorders undergoing donor stem cell transplantation. A donor transplantation uses blood-making cells from a family member or unrelated donor to remove and replace abnormal blood cells. Graft versus host disease is a reaction of the donor's immune cells against the patient's body. Itacitinib plus standard treatment may help prevent graft versus host disease in patients who have received a donor stem cell transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Fludarabine; Fludarabine phosphate; Methotrexate; Tacrolimus

Criteria

Inclusion Criteria:

• Karnofsky performance status of at least 70

• Patients with hematological disorders undergoing ASCT with conditioning regimen of timed sequential busulfan and fludarabine

• Human leukocyte antigen (HLA)-identical sibling or 8/8 matched unrelated 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

• Serum creatinine less than 1.5 x the upper limit of normal range and creatinine clearance greater than 50 ml/min

• Diffusing capacity for carbon monoxide (DLCO) 65% of predicted corrected for hemoglobin

• Left ventricle 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 until at least 30 days after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate

Exclusion Criteria:

• Patients with a comorbidity score > 3. The principal investigator is the final arbiter of eligibility and enrollment of patients with comorbidity score > 3 and may permit enrollment of these patients on individual basis

• 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 uncontrolled infections

• Patients with active hepatitis B and C