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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06547866 | Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia | PHASE2 | NOT YET_RECRUITING | 102 | — | — | Dec 1, 2025 | Dec 31, 2031 | Nov 26, 2025 | 37 | France |
| NCT06561347 | Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM | PHASE2 | RECRUITING | 55 | — | — | Dec 20, 2024 | Dec 1, 2027 | Mar 31, 2026 | 5 | United States |
Number of subjects achieving a CR or VGPR at any time during the course of treatment
Assessed using 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria. All participants will be gauged for very good partial response (VGPR) rate or better.
| Arm | Type | Description |
|---|---|---|
| Zanubrutinb + BGB-11417 | EXPERIMENTAL | cf intervention |
| Zanubrutinib + Bendamustine + Rituximab | EXPERIMENTAL | Zanubrutinib will be taken orally once daily on days 1-28 of cycles 1-15. Bendamustine will be given by intravenous infusion over about 10 to 60 minutes on days 1 and 2 of cycles 1 to 4. Rituximab will be given by intravenous infusion over about 30 minutes on day 1 of cycles 1 to 4. Drug diaries will be provided to participants to document information about the study treatment being taken. |
| Name | Type | Description |
|---|---|---|
| zanubrutinib + BGB-11417 | DRUG | The investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and BGB-11417.Treatment will be administered for a total of twenty 28 day cycles: Cycle 1 with zanubrutinib only Cycle 2 with zanubrutinib plus BGB-11417 ramp-up cycle 2, day 1 : 10mg cycle 2, day 2 : 20 mg cycle 2, day 3 : 40mg cycle 2, day 4-7 : 80md daily cycle 2, day 8 and beyond : 160 mg daily Cycles 3-20 with zanubrutinib plus BGB-11417 full dose |
| Zanubrutinib | DRUG | A potent, specific, and irreversible Bruton tyrosine kinase (BTK) inhibitor |
| Bendamustine | DRUG | Alkylating agent |
| Rituximab | DRUG | Monoclonal antibody |
Inclusion Criteria: 1. Be ≥ 18-year-old. 2. Have received at least 1 prior line of treatment (excluding treatment with any BTKi or Bcl-2 antagonist, see non-inclusion criteria). 3. Provide written informed consent. 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3. 5. Have...