Celecoxib Plus R-CHOP vs R-CHOP in Newly Diagnosed Advanced CD5+ DLBCL

Recruiting now · Phase 2

Conditions studied: Diffuse Large B-Cell Lymphoma (DLBCL), CD5 Positive

In brief

To evaluate the efficacy of celecoxib combined with R-CHOP versus R-CHOP in the treatment of newly diagnosed advanced CD5-positive diffuse large B-cell lymphoma (CD5+ DLBCL).The primary endpoint is Complete Response Rate (CRR)

Key facts

Study ID

NCT07494565

Run by

Sun Yat-sen University

People needed

60

Starts

2026-03-06

Expected to finish

2029-05-05

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years and ≤ 80 years, either gender, life expectancy > 6 months.
• Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL), CD20-positive, and immunohistochemically CD5-positive .
• Note: Patients must provide a local pathological report before screening or sufficient fresh or paraffin-embedded tissue to confirm the CD5+ IHC result.
• No prior therapy for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except palliative local radiotherapy for tumor-related symptoms), or surgical treatment (except tumor/pathologic biopsy and non-lymphoma-directed surgical resection).
• At least one assessable or measurable lesion according to the Lugano 2014 criteria:
• Lymph node lesion: longest diameter > 1.5 cm;
• Extranodal lesion: longest diameter > 1.0 cm.
• International Prognostic Index (IPI) score 0-5, stage III-IV disease.
• ECOG performance status 0-2.
• Laboratory results must meet the following criteria prior to the first dose:
• Bone marrow function: WBC ≥ 3×10⁹/L, HGB ≥ 90 g/L, ANC ≥ 1.5×10⁹/L, PLT ≥ 80×10⁹/L;
• Liver function: TBIL ≤ 1.5×ULN; ALT or AST ≤ 2.5×ULN (≤ 5×ULN if liver involvement); ALP ≤ 3×ULN in patients without bone involvement;
• Renal function: serum creatinine ≤ 1.5×ULN, or estimated glomerular filtration rate ≥ 50 mL/min by the Cockcroft-Gault equation;
• PT, APTT, INR ≤ 1.5×ULN unless receiving anticoagulation.
• Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography at screening.
• Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment, agree to use effective contraception during study participation and for ≥ 12 months after the last dose.
• Male patients must agree to use effective contraception during study participation and for ≥ 3 months after the last dose.
• Understand and voluntarily provide written informed consent.
• --

You may not qualify if…

• History of primary or secondary central nervous system (CNS) lymphoma or CNS lymphoma involvement.
• Current or previous diagnosis of the following lymphoma subtypes: primary CNS DLBCL, primary mediastinal (thymic) large B-cell lymphoma, primary effusion DLBCL, double-hit DLBCL with BCL2 and MYC rearrangements, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classic Hodgkin lymphoma/Burkitt lymphoma (gray-zone lymphoma), primary cutaneous DLBCL, indolent lymphoma, Burkitt lymphoma, EBV-positive mucocutaneous ulcer, DLBCL associated with chronic inflammation, lymphomatoid granulomatosis, intravascular large B-cell lymphoma, ALK-positive large B-cell lymphoma, plasmablastic lymphoma, HHV8-positive DLBCL NOS, primary testicular lymphoma.
• Transformed lymphoma derived from other lymphoma types, including follicular lymphoma, marginal zone B-cell lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma.
• Previous organ transplantation or hematopoietic stem cell transplantation.
• Other malignancy diagnosed within 5 years prior to the first dose or concurrent malignancy, **except**:
• other malignancy treated with surgery alone and achieving disease-free survival (DFS) for 5 consecutive years; cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder cancer [Ta (non-invasive tumor), Tis (carcinoma in situ), T1 (tumor invades lamina propria)].
• Previous treatment with cytotoxic agents for other diseases (e.g., rheumatoid arthritis) within 5 years prior to the first dose, or previous use of any anti-CD20 antibody.
• Previous use of any monoclonal antibody within 3 months prior to the first dose.
• Participation in another interventional clinical trial within 3 months prior to the first dose.
• Known hypersensitivity or contraindication to any study intervention, including:
• Contraindications to celecoxib, including hypersensitivity to celecoxib (e.g., known sulfonamide allergy, history of asthma, urticaria, or other allergic reactions induced by NSAIDs);
• Active peptic ulcer or gastrointestinal bleeding;
• Known hypersensitivity to rituximab or murine monoclonal antibody products;
• Contraindication to any component of the CHOP regimen, including previous anthracycline therapy;
• Diabetic patients unable to tolerate prednisone in the regimen.
• Use of glucocorticoids > 30 mg/day prednisone or equivalent for indications other than lymphoma symptom control:
• If receiving corticosteroid therapy ≤ 30 mg/day prednisone or equivalent, a stable dose must be documented for at least 4 weeks before Cycle 1 Day 1;
• If urgent glucocorticoid therapy (up to 100 mg prednisone or equivalent for a maximum of 7 days, Days -7 to -1) is required for lymphoma symptom control before the first dose, all tumor assessments must be completed before glucocorticoid initiation.
• Major surgery (excluding diagnostic procedures) within 1 month prior to randomization.
• Severe peripheral or central nervous system disease, e.g., history of progressive multifocal leukoencephalopathy.
• Previous anti-DLBCL therapy, including chemotherapy, targeted therapy, immunotherapy, definitive radiotherapy with curative intent (except palliative non-curative radiotherapy), or surgical treatment (except biopsy).
• Adverse events from prior therapy not resolved to ≤ CTCAE Grade 1 (except Grade 2 peripheral neuropathy, alopecia, hypothyroidism controlled by hormone replacement, or type 1 diabetes mellitus well controlled with insulin).
• Administration of live attenuated viral vaccine within 1 month prior to enrollment.
• Uncontrolled infection (i.e., clinically unstable) requiring parenteral antibiotics, antivirals, or antifungals within 7 days before the first dose; prophylactic use is permitted.
• Active HBV infection or active HCV infection. Patients with controlled HBV/HCV may be included cautiously at the investigator's discretion after effective antiviral intervention.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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