Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06233110 | Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD | PHASE1 | RECRUITING | 30 | — | — | Oct 29, 2025 | Jul 1, 2029 | Jan 22, 2026 | 1 | United States |
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)
| Arm | Type | Description |
|---|---|---|
| Dose escalation phase: Dose level 0 | EXPERIMENTAL | Fostamatinib at dose level 0 (dose of 50mg QAM) in combination with standard of care ruxolitinib 10mg BID |
| Dose escalation phase: Dose level 1 | EXPERIMENTAL | Fostamatinib at dose level 1 (dose of 100mg QAM) in combination with standard of care ruxolitinib 10mg BID |
| Dose escalation phase: Dose level 2 | EXPERIMENTAL | Fostamatinib at dose level 2 (dose of 150mg QAM) in combination with standard of care ruxolitinib 10mg BID |
| Dose escalation phase: Dose level 3 | EXPERIMENTAL | Fostamatinib at dose level 3 (dose of 100mg BID) in combination with standard of care ruxolitinib 10mg BID |
| Candidate Dose #1 | EXPERIMENTAL | In the safety expansion cohort, subjects will be randomized to one of two candidate doses of fostamatinib (identified from the dose escalation phase) in combination with ruxolitinib 10mg BID. |
| Candidate Dose #2 | EXPERIMENTAL | In the safety expansion cohort, subjects will be randomized to one of two candidate doses of fostamatinib (identified from the dose escalation phase) in combination with ruxolitinib 10mg BID. |
| Name | Type | Description |
|---|---|---|
| Fostamatinib | DRUG | Fostamatinib will be administered as part of the initial dose escalation cohort and then two candidate doses will be identified to be administered for the safety expansion cohort. |
| Ruxolitinib | DRUG | Ruxolitinib 10mg BID will be administered in combination with Fostamatinib in each of the study arms. |
Inclusion Criteria 1. Patient is able and willing to provide written informed consent prior to any study related screening procedures are performed. 2. Age ≥ 18 years old at the time of informed consent 3. Have undergone allogeneic hematopoietic cell transplantation (HCT) from any donor source (mat...