NCT07397832

CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL

CRP Regimen (Chidamide, Rituximab and Polatuzumab Vedotin) in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL: Single-Arm, Open-Label, Multicenter Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma

Detailed description

This is a single-arm, open-label, multicenter Phase II trial to evaluate the feasibility, efficacy, and safety of the CRP regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in treating elderly patients with previously untreated double-expressor diffuse large B-cell lymphoma.

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	Chidamide	Chidamide: patients followed a step-dose escalation regimen (10mg BIW,15mg BIW, 20mg BIW). 21 days as a treatment cycle. The maximum number of treatment cycles is six.
DRUG	Rituximab	Day 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six.
DRUG	Polatuzumab Vedotin	Day 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six.
DRUG	Chidamide Maintenance	For patients assessed as being in PR or CR status after completion of combination therapy, maintenance therapy with chidamide is administered for one year at a dosage of 20 mg, BIW. Drug adjustments may be made based on the patient's tolerance, with reference to the drug prescribing information.

Timeline

• Start date: 2026-01-30
• Primary completion: 2028-07-30
• Completion: 2028-12-30
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: China