Celecoxib Plus R-CHOP vs R-CHOP in Newly Diagnosed Advanced CD5+ DLBCL (NCT07494565) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Celecoxib Plus R-CHOP vs R-CHOP in Newly Diagnosed Advanced CD5+ DLBCL
China60 participantsStarted 2026-03-05
Plain-language 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)
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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 .
✓. 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:
✓. 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:
✓. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography at screening.
Exclusion criteria
✕. 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.
What they're measuring
1
Complete Response Rate (CRR)
Timeframe: At the end of Cycle 2, 4, and 6 (each cycle is 21 days)
✕. 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\*\*:
✕. 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.