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

NCT07494565 | Recruiting Phase 2

• 1 other identifier: B2026-050-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL); CD5 Positive

Keywords

CD5+ DLBCL; Celecoxib; R-CHOP

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR)

  At the end of Cycle 2, 4, and 6 (each cycle is 21 days)

Secondary Outcomes (7)

• ORR [PR + CR]

  At the end of Cycle 2, 4, and 6 (each cycle is 21 days)

• OS

  Participants were followed every 4 weeks for survival until death, lost to follow-up or study closure (approximately 12 months after the last patient ended treatment).

• EFS

  From date of randomization until the date of first documented disease progression, relapse after CR, death from any cause, or initiation of new treatment for residual lesions after initial therapy, whichever came first, assessed up to 2 years.

• PFS

  From date of randomization until the date of first documented disease progression, relapse after CR, death from any cause, whichever came first, assessed up to 2 years.

• DoR

  DoR was assessed every 4 weeks from the date of first documented response (CR or PR) until disease progression, death, or study closure (approximately 12 months after last patient ended treatment).

Other Outcomes (1)

• Exploratory Objectives

  Assessment every 2 cycles (1 cycle = 21 days)

Study Arms (2)

Celecoxib Combined with R-CHOP

EXPERIMENTAL

Drug: Celecoxib Combined with R-CHOP

R-CHOP

ACTIVE COMPARATOR

Drug: R-CHOP

Interventions

R-CHOP DRUG

Drug Dose Administration Time Rituximab (Innovent) 375 mg/m², iv Day 1 Cyclophosphamide 750 mg/m², iv Day 1 Doxorubicin 50 mg/m², iv Day 1 Vincristine 1.4 mg/m² (max. 2 mg), iv Day 1 Prednisone 60 mg/m², po Days 1-5

R-CHOP

Celecoxib Combined with R-CHOP DRUG

Drug Dose Administration Time Rituximab (Innovent) 375 mg/m², iv Day 1 Cyclophosphamide 750 mg/m², iv Day 1 Doxorubicin 50 mg/m², iv Day 1 Vincristine 1.4 mg/m² (max. 2 mg), iv Day 1 Prednisone 60 mg/m², po Days 1-5 Celecoxib 200 mg, po, BID Days -3 to +2

Celecoxib Combined with R-CHOP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

R-CHOP protocol

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 27, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): March 5, 2028
• Study Completion (Estimated): May 5, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)