denotes an abstract that is clinically relevant.
denotes that this is a recommended PHD Trainee Session.
denotes that this is a ticketed session.Session: 627. Aggressive Lymphomas: Pharmacologic Therapies: Poster I
Hematology Disease Topics & Pathways:
Research, Clinical trials, Lymphomas, Clinical Research, Diseases, Aggressive lymphoma, Lymphoid Malignancies, Myeloid Malignancies
In recent years, most phase III clinical trials exploring first-line treatments for diffuse large B-cell lymphoma (DLBCL) have ended in failure, with the notable exception of the POLARIX study. This may be primarily due to the heterogeneity of DLBCL. Currently, the Pola-R-CHP regimen has emerged as one of the new standard first-line treatments for DLBCL. Given the heterogeneity of DLBCL, combining different therapeutic agents tailored to specific genetic subtypes may be a strategy to further improve first-line treatment efficacy. Therefore, we are planning to conduct a prospective, multicenter, randomized controlled trial to comparing the efficacy and safety of Pola-RCHP-X versus R-CHOP-X or Pola-R-CHP (NCT06516978).
Study Design and Methods:
This study aims to enroll 528 patients aged 18–80 years with an International Prognostic Index (IPI) score of 2–5, an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, diagnosed with CD20+ DLBCL, and who have not received prior systemic treatment. Eligible patients will be randomly assigned in a 1:1:1 ratio to one of the following three arms: Pola-RCHP-X, R-CHOP-X, or Pola-R-CHP.
Patients in the Pola-RCHP-X and R-CHOP-X arms will first receive one cycle of Pola-R-CHP or R-CHOP while undergoing genetic subtyping. From cycles 2 to 6, patients with MCD, BN2, or N1 subtypes will receive Pola-RCHP-orelabrutinib/ R-CHOP-orelabrutinib; those with the EZB-MYC+ subtype will receive Pola-RCHP-venetoclax/ R-CHOP-venetoclax; those with the EZB-MYC− subtype will receive Pola-RCHP-chidamide/R-CHOP-chidamide; those with TP53 mutations will receive Pola-RCHP-penpulimab/R-CHOP-penpulimab; and those with the ST2 subtype or NOS will receive Pola-RCHP-lenalidomide/R-CHOP-lenalidomide. This will be followed by two cycles of Rituximab monotherapy. Patients in the Pola-R-CHP arm will receive the standard 6 cycles of Pola-R-CHP followed by 2 cycles of Rituximab.
The primary endpoint of the study is progression-free survival at 24 months (PFS24) as assessed by the investigators. Secondary endpoints include investigator-assessed complete response (CR) rate, overall response rate (ORR), event-free survival (EFS), overall survival (OS), and safety.
Disclosures: No relevant conflicts of interest to declare.
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