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Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT07494565

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

A Phase 2 study testing Celecoxib Combined with R-CHOP and R-CHOP in people with Diffuse Large B-Cell Lymphoma (DLBCL) and CD5 Positive, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Celecoxib Combined with R-CHOP and R-CHOP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
6 Mar 2026to 5 May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.
  • 10. Understand and voluntarily provide written informed consent.
  • ---

Who cannot join

  • 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)].
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  • 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.
  • HIV infection and/or acquired immunodeficiency syndrome.
  • Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with study drug absorption.
  • Significant cardiovascular disease, including any of the following:
  • Cardiac insufficiency ≥ NYHA Class II, or LVEF < 50% by echocardiography;
  • History of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmia requiring continuous antiarrhythmic therapy;
  • Myocardial infarction, serious arrhythmia, or unstable angina within 6 months before the first dose;
  • History of clinically significant QTc prolongation, or QTc interval > 470 ms (females) / > 450 ms (males) at screening;
  • Other cardiovascular disease deemed inappropriate by the investigator;
  • Uncontrolled hypertension despite combination therapy with 2 antihypertensive agents (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on at least 2 measurements).
  • Pulmonary fibrosis or interstitial pneumonia (except radiologic interstitial changes without symptoms or functional impairment), or history of pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction.
  • Arterial or venous thrombotic event within 6 months before the first dose, including cerebrovascular accident (cerebral hemorrhage, cerebral infarction, transient ischemic attack), deep vein thrombosis, pulmonary embolism.
  • Patients with intermuscular vein thrombosis or infusion port-related thrombosis may be included if deemed low risk by the investigator.
  • 22. Renal failure requiring hemodialysis or peritoneal dialysis, or history of nephrotic syndrome.
  • 23. Current or previous autoimmune disease requiring treatment, except hypothyroidism on stable replacement therapy and type 1 diabetes mellitus.
  • 24. History of alcoholism or drug abuse. 25. Any other serious or unstable medical condition (other than excluded malignancies), psychiatric disorder, or condition that may compromise patient safety, informed consent, or compliance with study procedures, in the investigator's judgment.
  • 26. Pregnant or breastfeeding female patients, or fertile patients unwilling to use effective contraception.
  • 27. Patients deemed ineligible for the study by the investigator.
  • ---

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Sun Yat-sen University Cancer Center, 86-020-87343765, lizhm@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Prospective, Randomized, Open-Label, Phase II Study of Celecoxib Combined With R-CHOP Versus R-CHOP in Patients With Newly Diagnosed Advanced CD5-Positive Diffuse Large B-Cell Lymphoma (CD5+ DLBCL)

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)

Being tested
Celecoxib Combined with R-CHOP, R-CHOP
Keywords
CD5+ DLBCL, Celecoxib, R-CHOP
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Celecoxib Combined with R-CHOPDrug

    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

  • R-CHOPDrug

    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

Study groups in NCT07494565
Study groupRoleWhat they receive
Celecoxib Combined with R-CHOPExperimentalNot described
Receives: Drug: Celecoxib Combined with R-CHOP
R-CHOPActive comparatorNot described
Receives: Drug: R-CHOP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate (CRR)

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

Secondary outcomes (7)

  1. ORR [PR + CR]

    Overall Response Rate (ORR [PR + CR])

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

  2. OS

    Overall Survival (OS)

    Measured: 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).

  3. EFS

    Event-Free Survival (EFS)

    Measured: 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.

  4. PFS

    Progression-Free Survival (PFS)

    Measured: 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.

  5. DoR

    Duration of Response (DoR)

    Measured: 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).

  6. TTP

    Time to Progression (TTP)

    Measured: TTP was assessed every 4 weeks until disease progression, death, or study closure （approximately 12 months after last patient ended treatment).

  7. Incidence of Adverse events

    Incidence, severity, and relationship to study treatment of adverse events, graded according to NCI-CTCAE version 5.0.

    Measured: Day 1 and Day 21 of each cycle (each cycle is 21 days), through completion of 6 cycles, and 30 days after the last dose of study treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start6 Mar 2026
  3. Primary completion5 Mar 2028 (estimated)
  4. Study completion5 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07494565
Sponsor's protocol ID
B2026-050-01
Status last verified
Jul 2026
First submitted
5 Mar 2026
Last updated
22 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Celecoxib Combined with R-CHOP and R-CHOP in people with Diffuse Large B-Cell Lymphoma (DLBCL) and CD5 Positive, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate (CRR) (time frame: At the end of Cycle 2, 4, and 6 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07494565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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