Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease
Public ClinicalTrials.gov record NCT04294641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Study of Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: \- Chronic Graft Versus Host Disease (cGVHD) can occur after a person has had a stem cell or bone marrow transplant. In cGVHD, the donor cells attack the recipient's body. Researchers want to see if a drug called ibrutinib can block one of the proteins that lead to the immune reaction that causes cGVHD. Objective: \- To see if ibrutinib as a first-line treatment can help people with newly diagnosed cGVHD. Eligibility: \- People age 18 and older with newly diagnosed moderate or severe cGVHD Design: * Participants will be screened with: * Medical and medicine histories * Physical exam and vital signs * Electrocardiograms (to measure heart function) * Assessment of their ability to perform daily activities * Blood and urine tests * Assessment of their general well-being. * Participants will visit the Clinical Center every 2 weeks for the first 2 months. Then they will visit every 4 weeks. * Participants will take ibrutinib by mouth once every day of every cycle. One cycle is 28 days. Treatment will last up to 2 years. Participants will keep a medicine diary. * Participants will take tests to measure lung function. They may have computed tomography scans of their chest. They will complete questionnaires about their symptoms and how cGVHD is affecting their body and quality of life. They will repeat the screening tests. * Participants may have optional blood tests and/or skin biopsies to better understand the drugs effect on the body. * Participants will be contacted by phone 30 days after treatment ends. They will also be contacted once a year for 2 years to discuss how they are feeling and if they have taken any other medicines to treat cGVHD.
Study identification
- NCT ID
- NCT04294641
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Interventions
- Ibrutinib Drug
- ECG Diagnostic Test
- PFT's Diagnostic Test
- CT Diagnostic Test
- Steroid pulse (prednisone) Drug
- Voriconazole Drug
- Posaconazole Drug
- Azithromycin Drug
- Montelukast Drug
- Budesonide Drug
- Beclomethasone Drug
- Filgrastim Other
- Pegfilgrastim Other
- Erythropoietin Other
- Transfusions Other
- Oral/Skin biopsy Procedure
Drug · Diagnostic Test · Other + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 9, 2021
- Primary completion
- Jun 23, 2024
- Completion
- Sep 30, 2024
- Last update posted
- Jan 22, 2026
2021 – 2024
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
| Washington University, School of Medicine | St Louis | Missouri | 63110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04294641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 22, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04294641 live on ClinicalTrials.gov.