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NCT03689894 · ClinicalTrials.gov registry record · Phase 1
Ibrutinib Plus Rituximab for cGVHD Following Allo-SCT
A Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT03689894: Clinical Trial Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT03689894 is a Phase 1 study that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03689894, a Phase 1 study, was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Allogeneic stem cell transplant is used to treat a variety of blood cancers. However, graft-versus-host disease (GVHD) is a common condition that may occur after transplant. GVHD happens when the donor cells attack and damage the recipients' tissue. The standard medication to treat chronic graft-versus-host-disease (cGVHD) is corticosteroids. However, there are long-term side effects of steroid therapy, including risk of infection, bone loss and other health problems. In addition, some patients with cGVHD do not respond to standard steroid therapy. In these cases, medications to suppress the immune system may be used. The purpose of this study is to learn about the effects, both good and bad, of combining the drugs ibrutinib and rituximab for the treatment of cGVHD. Ibrutinib is Food and Drug Administration (FDA)-approved for the treatment of cGVHD which has not responded to steroid therapy. Rituximab is an investigational drug, which means it is not FDA approved for this particular use. Rituximab is currently approved for treatment of Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), and other conditions, but is not FDA approved for the treatment of cGVHD. However, rituximab has been used in a clinic setting for the treatment of cGVHD in a number of patients over the past few years, and has generally been well tolerated and shown some benefit. The combination of ibrutinib and rituximab is being studied in the treatment of certain types of lymphoma and chronic leukemia, but it has not yet been combined for patients with cGVHD. Because ibrutinib is not approved for this use when combined with rituximab, it is considered investigational in this study. In this form, the term "study drug" refers to ibrutinib and rituximab. This study will involve people who have chronic GVHD, have previously taken corticosteroids, and have either not benefited from treatment with corticosteroids or have been unable to successfully taper off steroids.
Primary Outcome
During dose escalation, subjects will be assessed for dose-limiting toxicities at each dose level.
Interventions
- DRUG Rituximab
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-04-11 |
| Est. Completion | 2021-09-20 |
| Phase | Phase 1 |
Why NCT03689894 stopped before completion
NCT03689894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT03689894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03689894 about?
NCT03689894 is a clinical study titled "Ibrutinib Plus Rituximab for cGVHD Following Allo-SCT". Allogeneic stem cell transplant is used to treat a variety of blood cancers. However, graft-versus-host disease (GVHD) is a common condition that may occur after transplant. GVHD happens when the donor cells attack and damage the recipients' tissue. The standard medication to treat chronic graft-ve...
What is the current status of trial NCT03689894?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2019-04-11. Estimated completion is 2021-09-20.
What interventions are being tested in trial NCT03689894?
The interventions under investigation include: Rituximab (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT03689894?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03689894's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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