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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03806179 | Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL | PHASE1 | COMPLETED | 7 | — | — | Oct 4, 2018 | Aug 8, 2022 | Dec 22, 2023 | 2 | Czechia, Norway |
Safety and tolerability of Betalutin in combination with rituximab as determined by the frequency and severity of adverse events (CTCAE v4.03) in the first 12 weeks after Betalutin
| Arm | Type | Description |
|---|---|---|
| 10 MBq/kg Betalutin with rituximab treatment | EXPERIMENTAL | 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years |
| 15 MBq/kg Betalutin with rituximab treatment | EXPERIMENTAL | 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years |
| Name | Type | Description |
|---|---|---|
| 10 MBq/kg Betalutin | DRUG | 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2 |
| 15 MBq/kg Betalutin | DRUG | 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2 |
Inclusion Criteria: * Patient must be ≥18 years at the time of signing the informed consent * ECOG performance status of 0-2 * Histologically confirmed diagnosis (by 2008 World Health Organization \[WHO\] classification) of follicular lymphoma (grade 1, 2 or 3a) * At least one (but not more than 3)...