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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Huilai Zhang
• Email: huilaizhangtz@163.com
• Phone: +86-18622221228

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

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• Pola‑R‑GemOx chemotherapy for relapsed/refractory DLBCL in patients who cannot have an autologous transplant

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• Mosunetuzumab and Polatuzumab Vedotin with split-dose CHP in older adults with DLBCL

  This phase 2 study tests whether adding Mosunetuzumab subcutaneous and Polatuzumab Vedotin to a split-dose CHP chemotherapy regimen helps elderly, newly diagnosed DLBCL patients who are frail or unfit.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.