This is a prospective, multicenter, open-label Phase Ib/II clinical study designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of lisatoclax in combination with R-CHOP or Pola-R-CHP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone
Lisaftoclax (400 mg or 600 mg) is added from the second cycle of chemotherapy.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Dose-limiting toxicity (DLT) for Phase 1b
To identify the DLT
Time frame: The first cycle (each cycle is 21 days) after lisaftoclax administration.
Complete response rate (CRR) for Phase 2
The proportion of patients who achieve complete response (CR)
Time frame: Up to 8 cycles (each 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 8 cycles (each 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
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