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This is a single-arm, prospective, multicenter, open-label phase Ib/II study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab and chidamide in previously untreated elderly patients with MYC/BCL2 double-expressor diffuse large B-cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polatuzumab Vedotin in Combination With Rituximab and Chidamide | Experimental | Participants receive polatuzumab vedotin in combination with rituximab and chidamide. Polatuzumab vedotin and rituximab are administered intravenously on Day 1 of each 21-day cycle according to the protocol-specified schedule. Chidamide is administered orally twice weekly, with an initial dose of 20 mg from Day 1 to Day 14, and at the RP2D dose level in the extension phase. Combination therapy is given for up to six cycles. Patients achieving complete response after combination therapy may receive chidamide monotherapy as maintenance treatment according to the study protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polatuzumab Vedotin | Drug | 1.8 mg/kg intravenously on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT for Phase 1b | To identify the dose-limiting toxicity | The first cycle after administration (each cycle is 21 days) |
| RP2D for phase Ib | To identify the recommended phase 2 dose | The first cycle after administration (each cycle is 21 days) |
| Complete response rate (CRR) for Phase 2 | The proportion of patients who achieve complete remission (CR). | Up to 6 cycles (every cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The proportion of patients who achieve complete response (CR) or partial response (PR). | Up to 6 cycles (every cycle is 21 days) |
| Duration of Response (DOR) | To investigate the preliminary anti-tumor efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD. PhD. | Contact | +8602087342823 | caiqq@sysucc.org.cn |
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| Rituximab (R) | Drug | 375 mg/m² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle. |
|
| Chidamide | Drug | 20 mg, po, biw |
|
| Up to 5 years |
| Progression-free survival (PFS) | To investigate the preliminary anti-tumor efficacy | Up to 5 years |
| Overall survival (OS) | To investigate the preliminary anti-tumor efficacy | Up to 5 years |
| ID | Term |
|---|---|
| C000600736 | polatuzumab vedotin |
| D000069283 | Rituximab |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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