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NCT04235036 · ClinicalTrials.gov registry record · Phase 2
Ibrutinib and Rituxan for Chronic GVHD
A Phase 2 study, sponsored by Northside Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT04235036 is a Phase 2 study that was terminated before completion, run by Northside Hospital. The registered enrollment target is 15 participants.
The verdict
NCT04235036, a Phase 2 study, was terminated before completion, sponsored by Northside Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a phase II trial evaluating the safety and efficacy of the combination of Ibrutinib and Rituximab as primary treatment of chronic GVHD. We plan to enroll 35 patients on this study. Patients will be formally monitored monthly for 12 months to evaluate for outcome and safety endpoints. All other assessments will be done at the physician's discretion or institutional standards. All patients, responders and treatment failures, will be followed for a period of one year from the time of initiation of therapy. The primary endpoint will be the proportion of patients that are alive and off all systemic IST at 12 months following initiation of treatment.
Interventions
- DRUG Rituximab
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2022-12-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04235036
The ClinicalTrials.gov registry entry for NCT04235036 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northside Hospital, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT04235036 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04235036 about?
NCT04235036 is a clinical study titled "Ibrutinib and Rituxan for Chronic GVHD". This is a phase II trial evaluating the safety and efficacy of the combination of Ibrutinib and Rituximab as primary treatment of chronic GVHD. We plan to enroll 35 patients on this study. Patients will be formally monitored monthly for 12 months to evaluate for outcome and safety endpoints. All oth...
What is the current status of trial NCT04235036?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2019-12-16. Estimated completion is 2022-12-23.
What interventions are being tested in trial NCT04235036?
The interventions under investigation include: Rituximab (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT04235036?
This trial is sponsored by Northside Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
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