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RECRUITING
NCT07397832
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2026-01-30

Completion Date

2028-12-30

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

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.

Locations (1)

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, Tianjin Municipality, China