Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02759731|
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : September 18, 2019
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.
To test the safety and effectiveness of baricitinib in people with cGVHD that has not responded to therapy.
Adults 18 and older with cGVHD that has not responded to therapy.
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:
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Graft vs Host Disease Chronic Graft-Versus-Host Disease||Drug: Baricitinib||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (SCT)|
|Actual Study Start Date :||November 1, 2016|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: Arm 1
Baricitinib starting at a dose of 2mg daily for 12 weeks. If the response at 12 weeks is a CR and there has not been a DLT, the dose will be remain at 2mg daily for an additional 12 weeks. If there has been a DLT within the first 4 weeks, the dose will be decreased to 1mg daily, and will continue at this dose as tolerated. If there has been DLT at this dose (1 mg), patients will be taken off treatment.
Cycle=28 days: Baricitinib: 1mg-4mg PO QD
Experimental: Arm 2
If the response is a PR or stable disease (from cohort 1), the dose will be increased to 4mg daily for an additional 12 weeks. If there has been a DLT within the first 4 weeks will have a dose reduction back to 2mg daily. For patients who experience cGVHD progression at any time within the first 12 weeks on 2mg daily, the dose can be increased to 4mg daily until 24 weeks.
Cycle=28 days: Baricitinib: 1mg-4mg PO QD
- To evaluate the safety of baricitinib [ Time Frame: every 2 weeks during the first 4 weeks of each dose level then every 4 weeks. ]Safety
- To evaluate the efficacy of baricitinib [ Time Frame: 24 weeks ]Efficacy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759731
|Contact: Steven Z Pavletic, M.D.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Steven Z Pavletic, M.D.||National Cancer Institute (NCI)|