NCT07511114

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective, open-label, multicenter, randomized controlled clinical study conducted among previously untreated CD20-positive DEL participants. Subjects who meet the inclusion/exclusion criteria will be randomly assigned in a 1:1 ratio to either the test group or the control group after signing the informed consent form: 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 based on gene subtypes is conducted into C1, C2-3, and TP53mut types, which determines the medication for the remaining 5 cycles. For C1 type, PD1 inhibitors are added; for C2 and C3 types, BTK inhibitors are added; for TP53mut type, decitabine is added. If assigned to the control group, they will continue to receive CR-CHOP for up to 6 cycles. After each chemotherapy session, a routine evaluation is conducted. After completing three sessions, a comprehensive objective efficacy evaluation is performed. Patients with CR or PR in the efficacy evaluation continue with the original treatment regimen. For patients with SD or PD, second-line salvage therapy is recommended. After completing all treatments, the first summary evaluation is conducted. Patients with CR enter maintenance therapy with chidamide (maintenance for 2 years is recommended unless intolerable toxicity occurs or disease progresses) or undergo autologous hematopoietic stem cell transplantation. If CR is not achieved, the second-line regimen should be switched. After a follow-up of 2 years, the second summary evaluation is conducted. Before treatment, patients with large tumors may be recommended for radiation therapy in the corresponding area based on the doctor's judgment after completing six sessions of treatment (radiation dose is 30-40 Gy; however, it mainly depends on specific treatment principles). Additionally, the treating physician may decide whether to perform radiation therapy for extranodal lesions based on specific circumstances.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-03-31
• Completion: 2030-03-31
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: China