MedTrace Logo

Itacitinib for the Prevention of Graft Versus Host Disease

NCT04859946 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • Hematologic and Lymphocytic Disorder

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo stem cell transplant

DRUG

Busulfan

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

DRUG

Itacitinib

Given PO

DRUG

Tacrolimus

Given IV or PO

DRUG

Thiotepa

Given IV

Sponsors & Collaborators

Principal Investigators

  • Uday R Popat, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2027-04-01
Completion
2027-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04859946 on ClinicalTrials.gov