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Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

NCT02759731 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-10-08

Study results available
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Summary

Background:

Chronic graft versus host disease (cGVHD) can affect people who had a hematopoietic stem cell transplant using donor cells. It is often fatal. It is usually treated with high doses of steroids. But that helps only about half the people in the long term. Researchers want to see if a drug called baricitinib can help people with cGVHD that has not responded to therapy. The drug inhibits the proteins involved in communication in the immune system. These proteins may play a role in cGVHD and other inflammatory diseases.

Objectives:

To test the safety and effectiveness of baricitinib in people with cGVHD that has not responded to therapy.

Eligibility:

Adults 18 and older with cGVHD that has not responded to therapy.

Design:

Participants will be screened with a medical history, physical exam, and blood and urine tests. They will have lung and heart tests and chest scans.

Baseline visit: Participants will have:

Medical history

Physical exam

Blood tests

Tests for infectious diseases

Skin, eye, and teeth evaluations

Rehabilitation and occupational medicine evaluations

Photos of any lesions

Gynecology evaluation (females)

The study will occur in 28-day cycles. Participants will take the study drug by mouth every day for 3 cycles. Some will take it for 3 or 6 more cycles.

Participants will have a few visits during each cycle. They will repeat some previous tests. They may also have scans and questionnaires.

Participants will have a visit when they stop taking the drug and another 3 months later. They will repeat a few study tests. They will have follow-up calls for 2 years.

Conditions

  • Chronic Graft vs Host Disease
  • Chronic Graft-Versus-Host Disease

Interventions

DRUG

Baricitinib

Cycle=28 days: Baricitinib: 1mg-4mg by mouth (PO) every day (QD)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Steven Z Pavletic, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2022-06-30
Completion
2024-05-30
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 NCT02759731 on ClinicalTrials.gov