CRP regimen for older adults with untreated double‑expressor diffuse large B‑cell lymphoma

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

This trial will try the CRP drug combination (chidamide, rituximab, and polatuzumab vedotin) as first-line treatment for older adults with previously untreated double-expressor DLBCL.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Rituximab, Polatuzumab
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07397832 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label Phase II trial testing the CRP regimen (chidamide, rituximab, polatuzumab vedotin) with chidamide maintenance in elderly patients with previously untreated double-expressor DLBCL. Eligible participants have CD20-positive DLBCL with concurrent C-MYC and Bcl-2 expression and at least one measurable PET-CT lesion per Lugano criteria. The study will enroll older adults (≥70 years, or 60–69 with ECOG 2–4) and monitor feasibility, response rates, and safety outcomes. Treatment and scheduled assessments will be performed at the sponsoring hospital with regular imaging and laboratory monitoring.

Who should consider this trial

Good fit: Ideal candidates are older adults (age ≥70, or 60–69 with ECOG 2–4) with newly diagnosed, untreated CD20-positive DLBCL showing concurrent C-MYC and Bcl-2 expression and at least one measurable PET-avid lesion.

Not a fit: Patients who are younger without the double-expressor phenotype, those with prior lymphoma therapy, or those with significant organ dysfunction or contraindications to the study drugs are unlikely to benefit.

Why it matters

Potential benefit: If successful, the regimen might offer an effective and better-tolerated first-line option for older patients with double-expressor DLBCL who are often unable to tolerate standard chemotherapy.

How similar studies have performed: Polatuzumab-based combinations and rituximab-containing regimens have shown benefit in DLBCL, but adding the HDAC inhibitor chidamide as frontline therapy for double-expressor elderly patients is relatively novel with limited prior data.

Eligibility criteria

Inclusion Criteria:

1. Patients aged ≥70 years, or patients aged 60-69 years with an ECOG performance status score of 2-4. Both males and females are eligible.
2. No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy directed at the lymphoma (excluding palliative radiotherapy for symptom relief), or surgical therapy (excluding diagnostic biopsy or surgery not targeting the lymphoma).
3. Histopathological confirmation meeting all of the following conditions:

   1. Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20 positivity; concurrent positive expression of C-MYC and Bcl-2 (double-expressor phenotype).
   2. At least one measurable lesion positive on ¹⁸F-FDG PET-CT scan according to the Lugano 2014 criteria for Hodgkin and non-Hodgkin lymphoma.
4. Laboratory tests at screening must meet the following criteria, unless the investigator attributes abnormalities to lymphoma (no corrective or supportive therapy for these parameters within 2 weeks prior to assessment):

   1. Hematology: Hb ≥90 g/L, ANC ≥1.5 × 10⁹/L, PLT ≥90 × 10⁹/L.
   2. Biochemistry: Cr ≤1.5 ×ULN; TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (for patients with liver involvement: ≤5 × ULN).
5. Life expectancy of at least 6 months, as judged by the investigator.
6. Ability to understand and voluntarily provide written informed consent.

Exclusion Criteria:

1. History of or concurrent other active malignancies.
2. Prior treatment with Chidamide and/or R-CHOP. Contraindication to any component of CHOP, including prior anthracycline therapy. History of severe hypersensitivity or anaphylaxis to humanized or murine monoclonal antibodies, or known sensitivity/allergy to murine products.
3. Current diagnosis of any of the following: Follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma); Primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; Central nervous system (CNS) lymphoma (primary or secondary); Primary effusion DLBCL; Primary cutaneous DLBCL, leg type.
4. History of myocardial infarction, unstable angina, or other clinically significant cardiac disease within 12 months prior to signing informed consent; or prior coronary angioplasty/stenting within 12 months.
5. Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage.
6. Pregnant or lactating women.
7. Participation in any other clinical trial within 6 months prior to signing informed consent.
8. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Cancer Insititute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Huilai Zhang

Conditions Diffuse Large B-Cell Lymphoma