NCT07494565招募中2 期
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)
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Complete Response Rate (CRR)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
- •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.
- •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.
结局指标
主要结局
Complete Response Rate (CRR)
时间窗: At the end of Cycle 2, 4, and 6 (each cycle is 21 days)
次要结局
- 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).)
- TTP(TTP was assessed every 4 weeks until disease progression, death, or study closure （approximately 12 months after last patient ended treatment).)
- Incidence of Adverse events(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.)
研究者
Li Zhiming
Principal Investigator
Sun Yat-sen University
研究点 (1)
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