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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
1.8 mg/kg intravenously on Day 1 of each 21-day cycle.
375 mg/m² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle.
20 mg, po, biw
DLT for Phase 1b
To identify the dose-limiting toxicity
Time frame: The first cycle after administration (each cycle is 21 days)
RP2D for phase Ib
To identify the recommended phase 2 dose
Time frame: 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).
Time frame: Up to 6 cycles (every cycle is 21 days)
Overall response rate (ORR)
The proportion of patients who achieve complete response (CR) or partial response (PR).
Time frame: Up to 6 cycles (every cycle is 21 days)
Duration of Response (DOR)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 5 years
Progression-free survival (PFS)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 5 years
Overall survival (OS)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.