CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL
NCT07397832 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2026-02-09
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
Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
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
-
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.
Sponsors & Collaborators
-
Tianjin Medical University Cancer Institute and Hospital
lead OTHER
Principal Investigators
-
Huilai Zhang · Tianjin Medical University Cancer Insititute & Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-30
- Primary Completion
- 2028-07-30
- Completion
- 2028-12-30
Countries
- China
Study Locations
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