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NCT02611063 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Fostamatinib in Patients With cGVHD After Allogeneic Stem Cell Transplant
A Phase 1 study, sponsored by Stefanie Sarantopoulos, MD, PhD..
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02611063: Completed Phase 1 study, sponsored by Stefanie Sarantopoulos, MD, PhD..
NCT02611063 is a Phase 1 study that has completed, run by Stefanie Sarantopoulos, MD, PhD.. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02611063, a Phase 1 study, has completed, sponsored by Stefanie Sarantopoulos, MD, PhD..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate whether fostamatinib, a drug that blocks activated B cells will be effective in preventing and treating chronic graft vs host disease (cGVHD) after allogeneic stem cell transplant. Activated B cells may play a role in development of cGVHD. Inhibiting the B cell activation using fostamatinib after allogeneic stem cell transplant may prevent the development of cGVHD.
Primary Outcome
three dose levels are considered: 100 mg qd, 150 mg qd, 100 mg bid dose limiting toxicity is any of the following 1. Grade \> or = II aGVHD of the gut or liver or Grade III aGVHD of the skin lasting \> 7 days and related to the agent 2. Grade 3 toxicity from the agent in the cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary or neurologic categories that lasts \> 5 days 3. fostamatinib related mortality (TRM) 4. absolute neutrophil count (ANC) of Grade 3 or 4 plus
Interventions
- DRUG fostamatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2016-01 |
| Est. Completion | 2022-02-22 |
| Phase | Phase 1 |
What the finished NCT02611063 record still lists
NCT02611063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which fostamatinib is the first listed.
NCT02611063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02611063 about?
NCT02611063 is a clinical study titled "Evaluation of Fostamatinib in Patients With cGVHD After Allogeneic Stem Cell Transplant". The purpose of this study is to evaluate whether fostamatinib, a drug that blocks activated B cells will be effective in preventing and treating chronic graft vs host disease (cGVHD) after allogeneic stem cell transplant. Activated B cells may play a role in development of cGVHD. Inhibiting the B ce...
What is the current status of trial NCT02611063?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2016-01. Estimated completion is 2022-02-22.
What interventions are being tested in trial NCT02611063?
The interventions under investigation include: fostamatinib (DRUG).
Who is sponsoring clinical trial NCT02611063?
This trial is sponsored by Stefanie Sarantopoulos, MD, PhD., which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02611063's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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