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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07012980 | Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL | PHASE2 | NOT YET_RECRUITING | 38 | — | — | Jun 1, 2025 | Jul 31, 2026 | Jun 10, 2025 | - | — |
defined as the time from the day of inclusion until disease progression (PD) or relapse after complete remission (CR) as per Lugano Classification of 2014, or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Glofitamab, polatuzumab vedotin and zanubrutinib | EXPERIMENTAL | Glofitamab will be administered i.v. on a step-up dosing schedule starting on Day 8 of Cycle 1 (2.5 mg), Day 15 of Cycle 1 (10 mg), followed by 30 mg on Day 1 of Cycles 2-6, with each cycle being 21 days. A single dose of obinutuzumab 1000 mg will be administered intravenously on Day 1 of Cycle 1. Polatuzumab vedotin (1.8 mg/kg) will be administered intravenously on Day 2 of Cycle 1 and on Day 1 of the subsequent Cycle 2-6 (each Q3W). Zanubrutinib (160mg bid p.o.) will be administered for 7 days as pretreatment and from D1 to D21 through all 12 cycles Q3W. |
| Name | Type | Description |
|---|---|---|
| Glofitamab | DRUG | Glofitamab will be administered i.v. on a step-up dosing schedule starting on Day 8 of Cycle 1 (2.5 mg), Day 15 of Cycle 1 (10 mg), followed by 30 mg on Day 1 of Cycles 2-6, with each cycle being 21 days. A single dose of obinutuzumab 1000 mg will be administered intravenously on Day 1 of Cycle 1. |
| Polatuzumab Vedotin | DRUG | Polatuzumab vedotin (1.8 mg/kg) will be administered intravenously on Day 2 of Cycle 1 and on Day 1 of the subsequent Cycle 2-6 (each Q3W). |
| Zanubrutinib | DRUG | Zanubrutinib (160mg bid p.o.) will be administered for 7 days as pretreatment and from D1 to D21 through all 12 cycles Q3W. |
Inclusion Criteria: Subjects will only be included in the study if they meet all the following criteria: 1. Written informed consent. 2. Aged 70 years old or above. 3. ECOG performance status of 0-3. 4. Histologically confirmed CD20 positive DLBCL. 5. At least one measurable site of disease. 6. Pa...