Phase 4 Lymphoma Trial, Recruiting NCT06134284 Sponsor: Lixia Sheng Condition: Lymphoma
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Phase 4 Lymphoma Trial, Recruiting

NCT06134284
Recruiting Phase 4

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 old, of any sex or gender
  • People whose marginal zone lymphoma (a type of slow-growing blood cancer) has been confirmed through tissue testing (biopsy), or who meet specific minimum diagnostic criteria for the splenic form of this cancer
  • People who have at least one measurable area of cancer that can be seen on a CT or MRI scan — either a lymph node larger than 1.5 cm, or a lesion in another part of the body larger than 1.0 cm
  • People whose doctor has decided they need whole-body (systemic) treatment for their marginal zone lymphoma
  • People who have already received at least one course of systemic lymphoma treatment (such as immunotherapy or chemotherapy combined with immunotherapy), and whose cancer either did not respond well enough or came back after responding
  • People with a general physical performance score of 0–2 on the ECOG scale, meaning they are fully active to somewhat limited in strenuous activity (confirm with trial site)
  • People whose blood counts, liver and kidney function, blood clotting, and heart function meet specific health thresholds measured within 7 days before starting treatment (confirm specific values with trial site)
  • People expected to survive for at least 3 months
  • Men who have not had sterilisation and who agree to use barrier contraception during treatment and for at least 3 months after the last dose, and who agree to ask their partner to use an additional form of contraception
  • Women who have not had sterilisation and who agree to use contraception (such as oral contraceptives, an intrauterine device, or barrier contraception) starting at least 28 days before the first dose, throughout treatment, and after the last dose
  • People who are willing to sign a written informed consent form before any trial screening begins

Who may not be able to join:

  • People who have previously been treated with the combination of obutinib and rituximab (the study drugs) and whose cancer did not respond — meaning it did not reach at least a partial remission within 4 treatment cycles
  • People with a history of severe allergic reactions to monoclonal antibody therapies (a type of targeted treatment)
  • People known to be allergic to any of the drugs used in this trial
  • People with a current or past history of another cancer, unless that cancer was treated with the intent to cure and there has been no sign of recurrence or spread for at least 5 years
  • People whose lymphoma has spread to the central nervous system (brain or spinal cord)
  • People with serious or uncontrolled heart problems, including heart failure, unstable chest pain, a heart attack within the past 6 months, certain heart rhythm problems, a weak pumping function of the heart, certain inherited heart muscle diseases, a history of significantly prolonged heart electrical intervals, symptoms from heart disease requiring medication, or high blood pressure that is very difficult to control despite multiple medications
  • People who have had active bleeding within the 2 months before screening, are currently taking blood-thinning (anticoagulant) medications, or who the doctor believes have a clear tendency to bleed
  • People with significant protein in their urine (2+ on testing) and a 24-hour urine protein measurement of 2 g or more
  • People with a history of deep vein thrombosis (blood clot in a vein) or pulmonary embolism (blood clot in the lungs)
  • People with significant digestive system problems that could affect how a drug is swallowed, absorbed, or moved through the body — such as an inability to swallow, chronic diarrhoea, or bowel obstruction — or people who have had their entire stomach removed
  • People who have previously received an organ transplant or an allogeneic bone marrow transplant (a transplant using donor cells)
  • People who have had major surgery within 6 weeks before screening, or minor surgery within 2 weeks before screening (inserting a vascular access device is not considered an exclusion)
  • People with an active infection, uncontrolled hepatitis B, positive hepatitis C antibodies, HIV/AIDS, or other serious infectious diseases
  • People with current lung conditions such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-related lung damage, drug-related lung inflammation, or severely reduced lung function
  • People who have previously been treated with certain targeted cancer drugs that affect specific cell signalling pathways, including BTK inhibitors, BCR pathway inhibitors (such as PI3K or Syk inhibitors), or BCL-2 inhibitors (confirm with trial site)

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 15 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Chen, First Affiliated Hospital of Ningbo University

Phone: 86-574-87085596

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Lixia Sheng
Registry
ClinicalTrials.gov
Start date
2 January 2023
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate

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: 15 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