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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06561048 | Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma | PHASE3 | RECRUITING | 150 | — | — | Oct 2, 2024 | Dec 1, 2028 | Apr 8, 2026 | 34 | United States, Australia +1 |
Time from first study treatment to first occurrence of progression (as assessed by the Independent Review Committee) or death, whichever occurs first
| Arm | Type | Description |
|---|---|---|
| Soquelitinib | EXPERIMENTAL | Participants will administer soquelitinib 200 mg orally twice daily for up to 2 years |
| Standard of Care | ACTIVE_COMPARATOR | Participants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years |
| Name | Type | Description |
|---|---|---|
| Soquelitinib | DRUG | Soquelitinib 200 mg tablets will be taken by mouth two times a day |
| Belinostat | DRUG | Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle |
| Pralatrexate | DRUG | Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle |
Inclusion Criteria: 1. Adult participants ≥18 years of age on the day of signing the informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymph...