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NCT06233110 · ClinicalTrials.gov registry record · Phase 1
Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD
A Phase 1 study of Chronic Graft Versus Host Disease, sponsored by Stefanie Sarantopoulos, MD, PhD..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06233110: Recruiting Phase 1 study of Chronic Graft Versus Host Disease, sponsored by Stefanie Sarantopoulos, MD, PhD..
NCT06233110 is a Phase 1 study of Chronic Graft Versus Host Disease that is actively recruiting participants, run by Stefanie Sarantopoulos, MD, PhD.. The registered enrollment target is 30 participants, below the 115-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06233110, a Phase 1 study of Chronic Graft Versus Host Disease, is actively recruiting participants, sponsored by Stefanie Sarantopoulos, MD, PhD..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label phase I study of fostamatinib in combination with ruxolitinib for the treatment of chronic GvHD with a suboptimal response to corticosteroids. The primary objective is to identify a minimum safe and biologically effective dose of fostamatinib when combined with standard of care ruxolitinib for the treatment of steroid refractory and steroid dependent cGVHD. The secondary objective is to estimate the efficacy of the combination of ruxolitinib and fostamatinib for the treatment of steroid refractory and steroid dependent cGVHD. The target enrollment is 24-30 subjects. The study will begin with an initial dose escalation cohort employing a modified 3+3 design to investigate up to three doses of fostamatinib. Using safety, efficacy, pharmacodynamic (PD), and pharmacokinetic data (PK), an interim assessment will be performed to determine two candidate doses of the biologically optimal dose to investigate further. A safety expansion cohort will be opened to backfill these two candidate doses up to a total 12 patients per dose, including those in the dose escalation cohort who received the candidate doses. Patients will then be randomized to one of these two candidate doses in the expansion. If there is an imbalance in the two expansion cohorts, the remaining patient slots after 1:1 randomization will be sequentially backfilled to a total of 12 patients per cohort. A final analysis of safety, efficacy, and PK/PD data in patients who received the two candidate doses will be conducted to determine a minimum safety and biologically effective dose, which will be the recommended phase II dose (RP2D). The primary hypothesis is that Fostamatinib combined with ruxolitinib is a safe therapy for and has synergistic activity in cGvHD. The recommended phase II dose will be determined by the study investigators in collaboration with the sponsors. The decision to select the recommended phase II dose will occur only after all patients in the part 1 have completed
Primary Outcome
Minimum safe and biologically effective dose will be determined by dose limiting toxicities and overall response rate of the combination regimen, as well as pharmacokinetic and pharmacodynamic markers of fostamatinib (if available)
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Fostamatinib
Study Locations (1)
North Carolina
- Duke - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-10-29 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 1 |
What NCT06233110 shows while recruiting
NCT06233110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 115-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 2 interventions - of which Ruxolitinib is the first listed.
NCT06233110 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06233110 about?
NCT06233110 is a clinical study titled "Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD". This is an open-label phase I study of fostamatinib in combination with ruxolitinib for the treatment of chronic GvHD with a suboptimal response to corticosteroids. The primary objective is to identify a minimum safe and biologically effective dose of fostamatinib when combined with standard of care...
What is the current status of trial NCT06233110?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-10-29. Estimated completion is 2029-07-01.
What conditions does trial NCT06233110 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease.
What interventions are being tested in trial NCT06233110?
The interventions under investigation include: Ruxolitinib (DRUG), Fostamatinib (DRUG).
Who is sponsoring clinical trial NCT06233110?
This trial is sponsored by Stefanie Sarantopoulos, MD, PhD., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06233110 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06233110's enrollment target sits among peer trials
30 20th of 30 higher than 11 of 30 other Chronic Graft Versus Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Graft Versus Host Disease 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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