Actively Recruiting
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
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-02-09
58
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the CRP regimen, which combines Chidamide, Rituximab, and Polatuzumab Vedotin, to treat elderly patients aged 60 and above who have not previously been treated for double-expressor diffuse large B-cell lymphoma (DLBCL). This Phase II, single-arm, open-label trial aims to evaluate how feasible, effective, and safe this combination therapy is for this specific group of lymphoma patients. Participants will receive a combination therapy of Chidamide, Rituximab, and Polatuzumab Vedotin for up to six treatment cycles, each lasting 21 days. Chidamide is given with a dose escalation schedule, Rituximab at 375 mg/m², and Polatuzumab Vedotin at 1.8 mg/kg on day 1 of each cycle. After completing combination therapy, patients who achieve partial or complete response may receive maintenance therapy with Chidamide for one year. Throughout the study, participants will be closely monitored for treatment response, including complete and overall response rates, progression-free survival, event-free survival, and overall survival over two years. Researchers will also assess treatment-related side effects and quality of life using specific questionnaires. The total participation may last up to two years, including treatment and follow-up periods.
CONDITIONS
Brief Title
CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 70 years or older, or aged 60-69 years with ECOG performance status score of 2-4
- Both males and females are eligible
- No prior treatment for diffuse large B-cell lymphoma, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy (except palliative radiotherapy), or surgical therapy (except diagnostic biopsy or surgery not targeting lymphoma)
- Diagnosis of diffuse large B-cell lymphoma with CD20 positivity and double-expressor phenotype (positive C-MYC and Bcl-2)
- At least one measurable lesion positive on 18F-FDG PET-CT scan according to Lugano 2014 criteria
- Laboratory tests meeting criteria for hemoglobin, neutrophil count, platelets, creatinine, bilirubin, ALT, and AST levels unless abnormalities are due to lymphoma
- Life expectancy of at least 6 months
- Ability to understand and voluntarily provide written informed consent
You will not qualify if you...
- History of or current other active malignancies
- Prior treatment with Chidamide and/or R-CHOP; contraindications to any CHOP components; severe hypersensitivity to monoclonal antibodies or murine products
- Diagnosis of follicular lymphoma grade 3B, grey zone lymphoma, primary mediastinal large B-cell lymphoma, Burkitt lymphoma, CNS lymphoma, primary effusion DLBCL, or primary cutaneous DLBCL leg type
- History of significant cardiac disease or coronary procedures within 12 months
- Clinically uncontrolled active infection or organ hemorrhage
- Pregnant or lactating women
- Participation in another clinical trial within 6 months
- Any condition making the patient unsuitable for study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks (6 cycles of 21 days each)
Participants receive combination therapy with Chidamide, Rituximab, and Polatuzumab Vedotin in cycles.
1 visit per cycle, up to 6 cycles
Duration - 1 year
Participants who achieve partial or complete response after combination therapy receive maintenance therapy with Chidamide.
Visits twice a week during maintenance therapy
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Insititute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
H
Huilai Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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