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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05099471 | Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia | PHASE2 | RECRUITING | 80 | — | — | Mar 21, 2025 | Mar 1, 2033 | May 5, 2026 | 14 | Germany, Greece |
CR / VGPR 12 months after randomization
| Arm | Type | Description |
|---|---|---|
| Venetoclax / Rituximab | EXPERIMENTAL | Cycle 1 (28-days cycle) Stepwise dose escalation of Venetoclax in all patients with a target dose of xy mg/d QD PO. Day 1-7: Venetoclax xy mg/d QD PO Day 8-14: Venetoclax xy mg/d QD PO Day 15-28: Venetoclax xy mg/d QD PO Cycle 2-12: Day 1: Rituximab 375 mg/m2 IV Day 1-28: Venetoclax xy mg/d QD PO |
| Dexamethasone / Rituximab / Cyclophosphamide | ACTIVE_COMPARATOR | Cycle 1-6: Day 1: Dexamethasone 20 mg PO Day 1: Rituximab 375 mg/m2 IV Day 1-5: Cyclophosphamide 100 mg/m2 BID PO |
| Name | Type | Description |
|---|---|---|
| Venetoclax; Rituximab | DRUG | Combination of venetoclax and rituximab |
| DRC | DRUG | Combination of Dexamethasone / Rituximab / Cyclophosphamide |
Inclusion Criteria: * Proven clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM (IWWM). Histopathology has to be perfomed before randomization but within the last 4 months before start of treatment. In addition, pathological specimens ha...