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

ConditionsDiffuse Large B-Cell Lymphoma (DLBCL)CD5 Positive

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorSun Yat-sen University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Lymph node lesion: longest diameter > 1.5 cm;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Celecoxib Combined with R-CHOP
Drug
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-CHOP
Drug
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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Celecoxib Combined with R-CHOPExperimental treatment 1 intervention

Group B: R-CHOPActive comparator 1 intervention

Trial outcomes

Primary outcomes

Complete Response Rate (CRR)

Time frame

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

Secondary outcomes

ORR [PR + CR]

Overall Response Rate (ORR \[PR + CR\])

Time frame

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

Overall Survival (OS)

Time frame

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

Event-Free Survival (EFS)

Time frame

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

Progression-Free Survival (PFS)

Time frame

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.

Other outcomes

Exploratory Objectives

Correlation of NGS-guided gene mutations, ctDNA, serum metabolomics, and lipidomics profiles with efficacy endpoints including CR, DFS, ORR, EFS, PFS, and OS. Correlation of baseline levels of CD5 expression, p-STAT3, FOXO3a/FOXO4, ABCC1 and other proteins with treatment efficacy. Changes in patient-reported outcomes from baseline assessed using EORTC QLQ-C30, EQ-5D-5L, and FACT-LymF.

Time frame

Assessment every 2 cycles (1 cycle = 21 days)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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