BridgeMD
Compares treatment options for Diffuse Large B-Cell Lymphoma (DLBCL)
Official title Celecoxib Plus R-CHOP vs R-CHOP in Newly Diagnosed Advanced CD5+ DLBCL
ClinicalTrials.gov ID: NCT07494565
What this study is testing
What is Celecoxib Combined with R-CHOP?
Celecoxib Combined with R-CHOP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b-cell lymphoma (dlbcl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- No prior therapy for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except palliative local...
- At least one assessable or measurable lesion according to the Lugano 2014 criteria:
- Lymph node lesion: longest diameter \> 1.5 cm;
You likely can't join 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...
- Transformed lymphoma derived from other lymphoma types, including follicular lymphoma, marginal zone B-cell lymphoma, and chronic lymphocytic...
- 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...
- Previous treatment with cytotoxic agents for other diseases (e.g., rheumatoid arthritis) within 5 years prior to the first dose, or previous use of...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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 treatment 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...
- 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...
- 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 \ 470 ms (females) / \> 450 ms (males) at screening; \- Other cardiovascular disease deemed...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.