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.
Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
Age ≥70 years, or age 60-69 years with frailty determined by comprehensive geriatric assessment (CGA).
Pathologically confirmed diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) with MYC/BCL2 double expression, and no double-hit or triple-hit lymphoma.
At least one measurable or evaluable lesion according to the Lugano 2014 criteria.
Other subtypes of DLBCL.
Lymphoma involvement in the central nervous system or meninges.
Active infections.
History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
Single group
Polatuzumab Vedotin
Drug1.8 mg/kg intravenously on Day 1 of each 21-day cycle.
Rituximab (R)
Drug375 mg/m² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle.
Chidamide
Drug20 mg, po, biw
DLT for Phase 1b
To identify the dose-limiting toxicity
RP2D for phase Ib
To identify the recommended phase 2 dose
Complete response rate (CRR) for Phase 2
The proportion of patients who achieve complete remission (CR).
Overall response rate (ORR)
The proportion of patients who achieve complete response (CR) or partial response (PR).
Duration of Response (DOR)
To investigate the preliminary anti-tumor efficacy
Progression-free survival (PFS)
To investigate the preliminary anti-tumor efficacy
Overall survival (OS)
To investigate the preliminary anti-tumor efficacy
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This trial is not recruiting at the moment. You can still explore other options:
