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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04294641
The ClinicalTrials.gov registry entry for NCT04294641 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ibrutinib is the first listed.
NCT04294641 reports 0 study locations.
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.
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