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NOT YET RECRUITING
NCT07511114
PHASE3

A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyping

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

Evaluate the efficacy and safety of C Pola R-CHP+X compared to CR-CHOP in the treatment of previously untreated patients with DEL

Official title: A Prospective, Open-label, Multicenter, Randomized Controlled Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated Double-expression Diffuse Large B-cell Lymphoma Under the Guidance of Genotyping

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2026-03-31

Completion Date

2030-03-31

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

C-Pola-R-CHP+X

The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment. Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles. For patients with C1D14 ctDNA LFC \< 3, stratification is based on gene subtypes, namely C1, C2-3, and TP53mut, which determines the medication for the remaining 5 cycles. For C1 subtype, a PD1 inhibitor is added; for C2 and C3 subtypes, a BTK inhibitor is added; for TP53mut subtype, decitabine is added.

DRUG

CR-CHOP

If assigned to the control group, they will continue to receive CR-CHOP for up to 6 cycles.

Locations (1)

No. 197 Ruijin 2nd Road, Huangpu District, Shanghai, Shanghai, Shanghai

Shanghai, China