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

NCT07511114 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-04-06

No results posted yet for this study

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

Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma
  • Double Expressor Lymphoma

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-03-31
Completion
2030-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511114 on ClinicalTrials.gov