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NCT02759731 · ClinicalTrials.gov registry record · Phase 1
Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 1 study of Chronic Graft Versus Host Disease and Chronic Graft vs. Host Disease, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02759731: Completed Phase 1 study of Chronic Graft Versus Host Disease and Chronic Graft vs. Host Disease, sponsored by National Cancer Institute (NCI).
NCT02759731 is a Phase 1 study of Chronic Graft Versus Host Disease and Chronic Graft vs. Host Disease that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 115-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02759731, a Phase 1 study of Chronic Graft Versus Host Disease and Chronic Graft vs. Host Disease, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
DLT is defined as any grade ≥3 non-hematologic or grade ≥4 hematologic adverse event, or hemoglobin \<6.5 g/dL, within 4 weeks of starting any dose level (1mg, 2mg, or 4 mg) except those that are clearly and incontrovertibly due to extraneous causes. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is severe. Grade 4 is life-threatening.
Conditions Studied
Interventions
- DRUG Baricitinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-11-01 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 1 |
What the finished NCT02759731 record still lists
NCT02759731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 115-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Baricitinib is the first listed.
NCT02759731 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02759731 about?
NCT02759731 is a clinical study titled "Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation". 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...
What is the current status of trial NCT02759731?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-11-01. Estimated completion is 2024-05-30.
What conditions does trial NCT02759731 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease, Chronic Graft vs. Host Disease.
What interventions are being tested in trial NCT02759731?
The interventions under investigation include: Baricitinib (DRUG).
Who is sponsoring clinical trial NCT02759731?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02759731 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02759731's enrollment target sits among peer trials
24 23rd of 30 higher than 8 of 30 other Chronic Graft Versus Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Graft Versus Host Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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