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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03053440 | A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM) | PHASE3 | COMPLETED | 201 | — | — | Jan 25, 2017 | Jun 21, 2022 | Oct 26, 2024 | 58 | United States, Australia +10 |
Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.
| Arm | Type | Description |
|---|---|---|
| Arm A : Ibrutinib | EXPERIMENTAL | Participants with the MYD88 mutation received Ibrutinib |
| Arm B: Zanubrutinib | ACTIVE_COMPARATOR | Participants with the MYD88 mutation received zanubrutinib |
| Name | Type | Description |
|---|---|---|
| BGB-3111 | DRUG | 160 mg PO BID until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor |
| Ibrutinib | DRUG | 420 mg PO QD until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor |
Key Inclusion Criteria: * Clinical and definitive histologic diagnosis of WM * Measurable disease, requiring treatment * Participants with no prior therapy for WM, must be considered inappropriate candidates for treatment with a standard chemoimmunotherapy regimen * Age ≥ 18 years old * Eastern Coo...