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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of acute grade 2-4 graft versus host disease (GVHD)
Secondary outcome measures
Cumulative incidence of limited, extensive, and moderate to severe chronic GVHD
GVHD-free relapse-free survival
Incidence of adverse events
+5 more

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
~1200
Itacitinib
2020
Completed Phase 3
~910
Cyclophosphamide
1995
Completed Phase 3
~3770
Busulfan
2008
Completed Phase 3
~1120
Tacrolimus
2011
Completed Phase 4
~4740
Thiotepa
2008
Completed Phase 3
~2150
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,290 Total Patients Enrolled
2 Trials studying Hematologic and Lymphocytic Disorder
50 Patients Enrolled for Hematologic and Lymphocytic Disorder
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,134 Total Patients Enrolled
Uday R PopatPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
497 Total Patients Enrolled
1 Trials studying Hematologic and Lymphocytic Disorder

Media Library

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT04859946 — Phase 1
Hematologic and Lymphocytic Disorder Research Study Groups: Supportive care (itacitinib)
Hematologic and Lymphocytic Disorder Clinical Trial 2023: Allogeneic Hematopoietic Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT04859946 — Phase 1
Allogeneic Hematopoietic Stem Cell Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04859946 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this research project?

"According to clinicaltrials.gov, this search for eligible candidates is ongoing and began on the 11th of January 2022 with a recent update being made available on August 1st."

Answered by AI

Has the Federal Drug Administration endorsed Busulfan as a viable treatment?

"Busulfan's safety is still in the early stages of exploration, so it has been assigned a score of 1. This indicates there is only minimal data to support its use and efficacy."

Answered by AI

To what extent have other experiments utilized Busulfan?

"Currently, 1022 clinical trials are researching Busulfan. Of those studies, 178 have reached Phase 3 status. Even though the majority of said research is located in Philadelphia, Pennsylvania there exist a total of 29693 sites looking into this treatment."

Answered by AI

Who qualifies for participation in this clinical experiment?

"This medical experiment has recruitment requirements for 30 individuals with graft versus host disease, between ages 18 and 70. Exact patient criteria includes a Karnofsky performance status of at least 70, life expectancy of three months or greater, direct bilirubin measurement no higher than one milligram/deciliter (mg/dL), alanine transaminase levels lower than the upper limit boundary of normal range multiplied by three (3xULN) creatinine clearance of 60 ml per minute or more, diffusing capacity for carbon monoxide 50% predicted corrected to take hemoglobin into account, and left ventricular ejection"

Answered by AI

What is the aggregate amount of participants in this trial?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study is presently recruiting participants; the trial was first posted in January 11th 2022 and has most recently been updated August 1st 2022. The research team seeks a total of 30 patients from one site."

Answered by AI

Does this trial accommodate elderly participants?

"This clinical trial is accepting individuals who are at least 18 years of age and below the age of 70."

Answered by AI

What applications is Busulfan commonly prescribed for?

"Busulfan is a useful medication for treating lung cancer, dermatitis, atopic diseases and also multiple sclerosis."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Itacitinib for the Prevention of Graft Versus Host Disease
2022. "Itacitinib for the Prevention of Graft Versus Host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04859946.
All > Graft Vs Host Disease
~9 spots leftby Apr 2025
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