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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: Clinical Trial Phase 2 study, sponsored by Northside Hospital.
NCT04235036 is a Phase 2 study that was terminated before completion, run by Northside Hospital. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary objective is to evaluate the efficacy of the combination of rituximab and ibrutinib versus the historical experience with rituximab alone in the upfront treatment of cGVHD. Patients will be followed for 12 months following the initiation of treatment to see if they remain off immunosuppressive therapy.
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 |
Why NCT04235036 stopped before completion
NCT04235036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT04235036 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04235036's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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