Phase 2 Lymphoma Trial, Recruiting NCT07494565 Sponsor: Sun Yat-sen University Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT07494565
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 to 80 years of any gender, with a life expectancy of more than 6 months.
  • People with a laboratory-confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) that tests positive for both the CD20 and CD5 proteins on the cancer cells.
  • People who have not previously received any treatment for DLBCL, such as chemotherapy, targeted therapy, immunotherapy, or surgery (except for a biopsy or palliative radiotherapy to relieve symptoms).
  • People with at least one measurable area of disease: a lymph node lesion longer than 1.5 cm, or a lesion in another part of the body longer than 1.0 cm.
  • People with stage III or IV disease and an IPI score between 0 and 5 (a standard scoring system doctors use to assess lymphoma risk).
  • People with a general health status rated 0, 1, or 2 on the ECOG scale, meaning they are able to carry out daily activities with little to no limitation (confirm with trial site).
  • People whose blood test results before starting the trial show that bone marrow, liver, kidney, and clotting functions are all within acceptable ranges as defined by the trial.
  • People whose heart pumping function (left ventricular ejection fraction) is at least 50% on an echocardiogram (heart ultrasound).
  • Women of childbearing age who have a negative pregnancy test within 7 days before joining, and who agree to use effective contraception during the trial and for at least 12 months after the last dose.
  • Men who agree to use effective contraception during the trial and for at least 3 months after the last dose.
  • People who are able to understand the trial and willing to sign a written consent form.

Who may not be able to join:

  • People who have had lymphoma involving the brain or spinal cord (central nervous system), either now or in the past.
  • People with specific subtypes of large B-cell lymphoma that are excluded from this trial, including but not limited to primary CNS DLBCL, primary mediastinal large B-cell lymphoma, double-hit DLBCL, Burkitt lymphoma, and several other named subtypes (confirm with trial site for the full list).
  • People whose current lymphoma has transformed from another type of lymphoma, such as follicular lymphoma or chronic lymphocytic leukaemia.
  • People who have previously had an organ transplant or a stem cell transplant.
  • People diagnosed with another cancer within the past 5 years, except for certain treated and fully resolved cancers such as early-stage cervical carcinoma in situ, non-melanoma skin cancer, or certain superficial bladder cancers.
  • People who have received cytotoxic (cell-killing) drugs for any condition within the past 5 years, or who have ever been treated with an anti-CD20 antibody medication.
  • People who have received any monoclonal antibody treatment within the 3 months before the trial starts.
  • People who have participated in another interventional clinical trial within the past 3 months.
  • People with known allergies or medical reasons that prevent them from taking any of the study medications, including celecoxib (for example, sulfonamide allergy or NSAID-related asthma), rituximab, or any part of the CHOP chemotherapy regimen.
  • People taking steroid medications (such as prednisone) at a dose above 30 mg per day for reasons unrelated to lymphoma symptom control.
  • People who have had major surgery (not including diagnostic procedures) within one month before joining the trial.
  • People with serious nervous system conditions, such as a history of progressive multifocal leukoencephalopathy (a severe brain infection).
  • People who have received any prior treatment specifically for DLBCL, including chemotherapy, targeted therapy, immunotherapy, curative-intent radiotherapy, or surgery (other than biopsy).
  • People who still have unresolved side effects from a previous treatment that are rated above Grade 1 severity, with certain exceptions such as mild nerve problems, hair loss, or well-controlled thyroid or diabetes conditions.
  • People who have received a live vaccine within one month before joining the trial.
  • People with an active, clinically unstable infection requiring intravenous antibiotics, antivirals, or antifungals within the 7 days before the trial starts.
  • People with active hepatitis B (HBV) or active hepatitis C (HCV) infection (those with controlled HBV or HCV may be considered at the treating doctor's discretion after effective antiviral treatment).
  • People with HIV infection or AIDS.
  • People who are unable to swallow tablets, or who have a condition affecting how the gut absorbs medication.
  • People with significant heart conditions, including heart failure, serious heart rhythm problems, a heart attack or unstable chest pain within the past 6 months, a prolonged QTc interval on an ECG, or blood pressure that remains very high despite taking two blood pressure medications.
  • People with pulmonary fibrosis, interstitial lung disease, or serious lung problems that cause symptoms or affect lung function.
  • People who have had a stroke, blood clot in a deep vein (DVT), or pulmonary embolism within the past 6 months (certain low-risk clotting events may be considered at the investigator's discretion).
  • People who require dialysis for kidney failure, or who have a history of nephrotic syndrome.
  • People with a current or past autoimmune disease that requires treatment, except for well-controlled thyroid conditions or type 1 diabetes.
  • People with a history of alcoholism or drug abuse.
  • People who are pregnant or breastfeeding, or people who are able to have children but are unwilling to use effective contraception.
  • People considered ineligible by the trial investigator for any other medical or safety reason.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
6 March 2026
Est. completion
5 March 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Complete Response Rate (CRR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov