Itacitinib for Graft-versus-Host Disease

Recruiting in Palo Alto (17 mi)

Uday R Popat | MD Anderson Cancer Center

Overseen byUday R. Popat

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-70 with blood disorders who are undergoing a stem cell transplant from a donor. They must have good organ function, agree to use contraception, and not be pregnant. People with serious heart conditions, active hepatitis B or C, or unresolved treatment side effects can't join.

Inclusion Criteria

Direct bilirubin not greater than 1 mg/dL

DLCO 50% of predicted corrected for hemoglobin

I can speak English or another language.

+11 more

Exclusion Criteria

My leukemia is in the first complete remission or chronic phase.

I still have side effects from previous treatments that are noticeable.

My donor for the transplant is a half-match and I have antibodies against their cells.

+3 more

Participant Groups

The study is testing if adding Itacitinib to standard treatments (Cyclophosphamide, Tacrolimus) after a stem cell transplant can prevent graft-versus-host disease—a condition where donor cells attack the patient's body.

1Treatment groups

Experimental Treatment

Group I: Supportive care (itacitinib)Experimental Treatment7 Interventions

CONDITIONING: Patients receive busulfan IV over 3 hours on days -20, -13, and -6 to -3, thiotepa IV on day -7, and fludarabine IV over 1 hour on days -6 to -3. STEM CELL TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4. Patients also receive itacitinib PO QD on days 5-60 in the absence of disease progression or unacceptable toxicity. Beginning day 5 after stem cell transplant, patients also receive tacrolimus IV over 24 hours until able to tolerate oral tacrolimus, whereby patients then receive tacrolimus PO BID.