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JAK1/2 Inhibitor
Baricitinib for Chronic Graft-versus-Host Disease
Phase 1 & 2
Waitlist Available
Led By Steven Z Pavletic, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years
Karnofsky performance score >50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date treatment consent signed to 30 days off study drug, approximately 73 months and 28 days.
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of baricitinib in people with cGVHD that has not responded to therapy.
Who is the study for?
Adults over 18 with chronic graft-versus-host disease (cGVHD) that hasn't improved after treatment, including high-dose steroids. Participants must have stable primary malignancy for at least 3 months and agree to use two forms of contraception. They should not be at high risk due to other medical conditions or taking investigational drugs.Check my eligibility
What is being tested?
The trial is testing Baricitinib's safety and effectiveness in treating cGVHD that's resistant to therapy. It involves daily oral doses over several 28-day cycles, with regular monitoring through physical exams, blood tests, scans, and questionnaires.See study design
What are the potential side effects?
Baricitinib may cause side effects such as infections due to immune suppression, changes in blood test results indicating liver or kidney issues, cholesterol level changes, and possibly others related to the drug’s effect on the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.
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My chronic GVHD hasn't improved with steroids or second treatments.
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I have been diagnosed with moderate or severe chronic GVHD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date treatment consent signed to 30 days off study drug, approximately 73 months and 28 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date treatment consent signed to 30 days off study drug, approximately 73 months and 28 days.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLT)
Phase 2: Number of Participants With Any Serious and/or Non-Serious Grades 3, 4, and/or 5 Adverse Events Due to Drug
Phase 2: Overall Response at 24 Weeks
Other outcome measures
Phase 1 and 2: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Trial Design
1Treatment groups
Experimental Treatment
Group I: BaricitinibExperimental Treatment1 Intervention
Single arm, intra-patient dose escalation. Arm 1 (starting dose) -Baricitinib starting at a dose of 2mg daily for 12 weeks. If the response at 12 weeks is a complete response (CR) and there has not been a dose-limiting toxicity (DLT), the dose will remain at 2mg daily for an additional 12 weeks. Arm 2 (dose escalation) - If the response is a partial response (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.
Each participant is exposed to both dose levels (with the exception of participants who developed toxicity or progressive disease that caused them to discontinue study early before they were able to undergo the per-protocol dose escalation at 12 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2017
Completed Phase 3
~9510
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,640 Previous Clinical Trials
40,930,510 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Steven Z Pavletic, M.D.Principal InvestigatorNational Cancer Institute (NCI)
15 Previous Clinical Trials
3,779 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a lung score of 3 according to the National Institutes of Health (NIH) grading system.I am on a stable or reducing dose of medication for cGVHD.My blood tests for organ and bone marrow function are normal.I do not have an uncontrolled infection like HIV, Hepatitis B, or Hepatitis C.I haven't had any cancer other than non-melanoma skin, cervical, or breast carcinoma in situ in the last 2 years.I have not started any new immune suppression or cGVHD treatment in the last 4 weeks.I haven't had a serious illness in the last month that would make this study risky for me.I am 18 years old or older.I am able to care for myself but may not be able to do active work.My original cancer has been stable for 3 months before joining the study.I agree to use two effective birth control methods during and for 7 days after the study.My chronic GVHD hasn't improved with steroids or second treatments.My cancer has come back or gotten worse and needs treatment.I have been diagnosed with moderate or severe chronic GVHD.My condition responds to JAK inhibitors, regardless of the affected organ.You are allergic to JAK inhibitors.You are currently taking any other experimental medications.
Research Study Groups:
This trial has the following groups:- Group 1: Baricitinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What pathologies has Baricitinib been found to ameliorate?
"Baricitinib is frequently prescribed to hospitalized patients, but can also help those suffering from coronavirus disease 2019 (COVID‑19), extracorporeal membrane oxygenation treatment, and rheumatoid arthritis."
Answered by AI
Are there still vacancies available for participants in this clinical trial?
"As indicated on clinicaltrials.gov, this research initiative is no longer recruiting individuals; it was first posted on November 1st 2016 and last updated in November 22nd 2022. Despite this fact, there are 206 other studies that are actively enrolling participants as of present day."
Answered by AI
Is it possible for me to join this research project?
"To become part of this trial, patients must have a diagnosis of graft vs host disease and should be between 18-99 years old. The study is currently open to 24 participants in total."
Answered by AI
Are there any precedent studies regarding the efficacy of Baricitinib?
"Currently, 31 trials for Baricitinib are ongoing with 15 trials in Phase 3. Although many of the studies for this drug take place in Pune (Maharashtra), a total of 1416 clinical trial sites around the world have been activated to study its efficacy."
Answered by AI
How many participants are being accepted into this clinical trial?
"This clinical trial is no longer open for enrollment. It was initially announced on November 1st 2016 and the last posting of data occurred on November 22nd 2022. Fortunately, there are currently 175 trials recruiting patients with graft vs host disease, as well as 31 studies looking to enroll individuals taking Baricitinib medication."
Answered by AI
Are seniors above the age of sixty admissible to this research trial?
"The age range for this study is limited to 18-99 years old. There are 73 trials available for those under the legal age and 176 studies geared towards participants over 65."
Answered by AI
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