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Anti-Inflammatory drug may boost chemo for aggressive lymphoma

NCT ID NCT07494565

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether adding the anti-inflammatory drug celecoxib to standard R-CHOP chemotherapy improves outcomes for people with newly diagnosed, advanced CD5-positive diffuse large B-cell lymphoma (a fast-growing type). Sixty participants will be randomly assigned to receive either celecoxib plus R-CHOP or R-CHOP alone. The main goal is to see if the combination leads to more complete remissions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Celecoxib (an anti-inflammatory drug) combined with R-CHOP chemotherapy
What this could lead to
If it works, this could improve the chance of complete remission for people with a hard-to-treat type of lymphoma.
What could go wrong
This is a small, early-phase trial (60 people) and may not show a clear benefit. Adding celecoxib could also increase side effects like stomach or heart problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years and ≤ 80 years, either gender, life expectancy \> 6 months. 2. 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. 3. 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). 4. 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. 5. International Prognostic Index (IPI) score 0-5, stage III-IV disease. 6. ECOG performance status 0-2. 7. 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. 8. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography at screening. 9. 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. \--- Exclusion Criteria: 1. History of primary or secondary central nervous system (CNS) lymphoma or CNS lymphoma involvement. 2. 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. 3. Transformed lymphoma derived from other lymphoma types, including follicular lymphoma, marginal zone B-cell lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma. 4. Previous organ transplantation or hematopoietic stem cell transplantation. 5. 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ), T1 (tumor invades lamina propria)\]. 6. 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. 7. Previous use of any monoclonal antibody within 3 months prior to the first dose. 8. Participation in another interventional clinical trial within 3 months prior to the first dose. 9. 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. 10. 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. 11. Severe peripheral or central nervous system disease, e.g., history of progressive multifocal leukoencephalopathy. 12. Previous anti-DLBCL therapy, including chemotherapy, targeted therapy, immunotherapy, definitive radiotherapy with curative intent (except palliative non-curative radiotherapy), or surgical treatment (except biopsy). 13. 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). 14. Administration of live attenuated viral vaccine within 1 month prior to enrollment. 15. Uncontrolled infection (i.e., clinically unstable) requiring parenteral antibiotics, antivirals, or antifungals within 7 days before the first dose; prophylactic use is permitted. 16. 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. 17. HIV infection and/or acquired immunodeficiency syndrome. 18. Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with study drug absorption. 19. 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). 20. 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. 21. 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. \---

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

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