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NCT04294641 · ClinicalTrials.gov registry record · Phase 2
Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT04294641: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT04294641 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04294641, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
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.
Primary Outcome
To evaluate the efficacy of Ibrutinib as a first-line treatment for persons with newly diagnosed chronic graft-versus-host disease (GvHD) overall response rate was measured using the 2014 National Institutes of Health (NIH) consensus criteria and reported with an 80% confidence interval. CR is defined as complete resolution in all of signs and symptoms at all affected organs or tissues. PR is defined as improvement in ≥1 organ or tissue with no progression in any other affected organ or tissue.
Interventions
- DRUG Ibrutinib
- DIAGNOSTIC_TEST CT
- DIAGNOSTIC_TEST ECG
- DIAGNOSTIC_TEST PFT's
- DRUG Steroid pulse (prednisone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-05-10 |
| Est. Completion | 2024-10-01 |
| Phase | Phase 2 |
What the finished NCT04294641 record still lists
NCT04294641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Ibrutinib is the first listed.
NCT04294641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04294641 about?
NCT04294641 is a clinical study titled "Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease". 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 t...
What is the current status of trial NCT04294641?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2021-05-10. Estimated completion is 2024-10-01.
What interventions are being tested in trial NCT04294641?
The interventions under investigation include: Ibrutinib (DRUG), CT (DIAGNOSTIC_TEST), ECG (DIAGNOSTIC_TEST), PFT's (DIAGNOSTIC_TEST), Steroid pulse (prednisone) (DRUG).
Who is sponsoring clinical trial NCT04294641?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04294641's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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