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

NCT04127721 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-10-29

No results posted yet for this study

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.

Conditions

  • Allogeneic Stem Cell Transplant Recipient
  • Hematologic and Lymphocytic Disorder
  • Hematopoietic and Lymphoid Cell Neoplasm

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo ASCT

DRUG

Busulfan

Given IV

DRUG

Fludarabine

Given IV

DRUG

Itacitinib

Given PO

DRUG

Methotrexate

Given IV

DRUG

Tacrolimus

Given IV and PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2020-09-22
Completion
2020-09-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04127721 on ClinicalTrials.gov