This is a prospective, multicenter, multi-cohort study of ctDNA combined with PET for predicting the efficacy of standard first-line therapy for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
Age ≥ 18 years old.
Previously untreated CD20-positive DLBCL patients, including the following types according to the 2016 WHO classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS) including germinal center B-cell type and activated B-cell type; T-cell/histiocyte-rich large B-cell lymphoma; Epstein - Barr virus-positive DLBCL, NOS; ALK-positive large B-cell lymphoma; HHV8-positive DLBCL, NOS; high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma); high-grade B-cell lymphoma, NOS.
Signed informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2, with an expected survival greater than 12 months.
Patients planned to receive short-cycle chemotherapy and radiotherapy.
Subjects judged by the investigator to have any factors affecting compliance with the protocol, including uncontrollable medical, psychological, family, sociological or geographical conditions; or unwilling or unable to comply with the procedures required in the study protocol.
Known human immunodeficiency virus (HIV) infection or positive immunassay.
Viral infections that cannot be controlled by antiviral drugs, such as herpesvirus active infection, acute or chronic active hepatitis B, acute or chronic active hepatitis C, etc. (Note: Chronic HBV carriers or inactive HBsAg-positive subjects with HBV-DNA below the detection limit can be enrolled, requiring clinical evaluation, and if appropriate, preventive antiviral treatment is required; HCV antibody-negative subjects can be enrolled, and HCV antibody-positive patients need to be tested for HCV-RNA, and if negative, they can be enrolled).
Newly diagnosed diffuse large B - cell lymphoma (DLBCL)
Cohort
Prospective
POLA-R-CHP
DrugPola-R-CHP treatment for 6 cycles (IPI score 2-5)
Correlation between combined PET/CT and ctDNA assessments after 2 cycles of R-CHOP or Pola-R-CHP therapy and progression-free survival (PFS)
Deauville criteria (PET), Lugano 2014 (response), ctDNA (Percentage reduction in ctDNA concentration by NGS kit) Progression-free survival (PFS): Defined as the period from the first administration of medication until disease progression or death from any cause.
Correlation between combined PET/CT and ctDNA assessments after 2 cycles of R-CHOP or Pola-R-CHP therapy and tumor response and overall survival (OS) in treatment-naive DLBCL patients
Real-world evaluation of complete response rate (CRR), overall response rate (ORR), progression-free survival (PFS), event-free survival (EFS), overall survival (OS), and safety profiles of R-CHOP or Pola-R-CHP regimens in treatment-naive diffuse large B-cell lymphoma (DLBCL) patients,ctDNA(positve or negative by NGS kit).
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