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Itacitinib for Graft-versus-Host Disease

Phase 1

Waitlist Available

Led By Uday R Popat

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 100 days after stem cell transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if itacitinib plus standard of care may help prevent GVHD in patients who have received an allogeneic transplant.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Itacitinib may cause infections, liver problems, low blood counts leading to bleeding/bruising/infections, and possibly increase cancer risk. Standard care drugs also have risks like kidney damage and immune system suppression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 100 days after stem cell transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 100 days after stem cell transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 100 days after stem cell transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of acute grade 2-4 graft versus host disease (GVHD)

Secondary study objectives

Cumulative incidence of limited, extensive, and moderate to severe chronic GVHD

GVHD-free relapse-free survival

Incidence of adverse events

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1240

Itacitinib

2020

Completed Phase 3

~980