Study on Predicting Response to Standard First-Line Treatment in Diffuse Large B-Cell Lymphoma (DLBCL) Patients Using ctDNA Combined With PET: A Prospective, Multicenter, Multicohort Investigation

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

• Have at least one measurable two-dimensional lesion determined by clinical examination, CT scan, or MRI: ① lymph nodes \> 1.5 cm; ② other non-lymph node lesions ≥ 1.0 cm.

• Good function of major organs: Hematological function: absolute neutrophil count ≥ 1,000/mm³, platelet count ≥ 75,000/mm³; Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤ 1.5× ULN (for patients with Gilbert syndrome, hilar compressive adenopathy-induced cholestasis, liver involvement or lymphoma-induced biliary obstruction \< 5 times ULN); Renal function: creatinine clearance \> 30 mL/min, creatinine ≤ 1.5× ULN; Pulmonary function: indoor oxygen saturation ≥ 95%; Cardiac function: no obvious cardiac insufficiency or cardiovascular disease.

• Fertile patients must be willing to take highly effective contraceptive measures during the study and within 120 days after the last administration of treatment.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Rong Tao, M.D
rtao@shca.org.cn
86-21-64175590
Backup
Wenhao Zhang
ZWHL98@foxmail.com
Time Frame
Start Date: 2025-05-09
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 300
Treatments
Pola-R-CHP treatment group (IPI score 2-5)
Pola-R-CHP treatment group (IPI score 2-5)
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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