RecruitingPhase 2NCT07397832

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


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

58 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specific chemotherapy combination called CRP (which includes rituximab, a targeted antibody drug) for elderly patients with a particularly aggressive type of lymphoma called double-expressor diffuse large B-cell lymphoma (DLBCL) — cancer where two specific proteins (MYC and Bcl-2) are both overactive, making the cancer harder to treat. **You may be eligible if...** - You are 70 or older, OR between 60 and 69 with limited physical function (ECOG score 2–4) - You have been newly diagnosed with CD20-positive DLBCL that is also double-expressor (both MYC and Bcl-2 positive) - You have not received any prior treatment for DLBCL - You have at least one measurable tumor visible on PET-CT scan - You are expected to live at least 6 months **You may NOT be eligible if...** - You have another active cancer - You have previously received CHOP chemotherapy or the drug chidamide - You have had a recent heart attack or serious heart condition - You are pregnant or breastfeeding - You have CNS (brain or spinal cord) lymphoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGChidamide

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.

DRUGRituximab

Day 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six.

DRUGPolatuzumab Vedotin

Day 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six.

DRUGChidamide 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.


Locations(1)

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07397832


Related Trials