Actively Recruiting
CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-02-09
58
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 patients aged 60-69 years with an ECOG performance status score of 2-4
- Both males and females are eligible
- No prior treatment for diffuse large B-cell lymphoma (DLBCL), including chemotherapy, targeted therapy, immunotherapy, local radiotherapy directed at lymphoma (except palliative radiotherapy), or surgery targeting lymphoma
- Histopathological diagnosis of DLBCL with CD20 positivity and concurrent positive expression of C-MYC and Bcl-2 (double-expressor phenotype)
- At least one measurable lesion positive on 18F-FDG PET-CT scan according to Lugano 2014 criteria
- Laboratory tests showing hemoglobin ≥90 g/L, absolute neutrophil count ≥1.5 × 10⁹/L, platelets ≥90 × 10⁹/L, creatinine ≤1.5 times upper limit of normal (ULN), total bilirubin ≤1.5 × ULN, ALT and AST ≤2.5 × ULN (≤5 × ULN if liver involvement)
- Life expectancy of at least 6 months as judged by the investigator
- Ability to understand and voluntarily provide written informed consent
You will not qualify if you...
- History of or active other malignancies
- Prior treatment with Chidamide and/or R-CHOP chemotherapy
- Contraindications to CHOP components, including prior anthracycline therapy
- History of severe hypersensitivity or anaphylaxis to humanized or murine monoclonal antibodies or known allergy to murine products
- Diagnosis of follicular lymphoma grade 3B, unclassifiable B-cell lymphoma with features between DLBCL and Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, Burkitt lymphoma, CNS lymphoma, primary effusion DLBCL, or primary cutaneous DLBCL leg type
- History of myocardial infarction, unstable angina, or significant cardiac disease within 12 months prior to consent, or prior coronary angioplasty/stenting within 12 months
- Clinically uncontrolled active infection or organ hemorrhage
- Pregnant or lactating women
- Participation in another clinical trial within 6 months prior to consent
- Any other condition making the patient unsuitable for participation according to the investigator
AI-Screening
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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
CONTACT
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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