Phase 2 Lymphoma Trial, Recruiting NCT07195799 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT07195799
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 or older of any gender
  • People who have been diagnosed with one of the following blood cancers, confirmed by laboratory testing of tissue: follicular lymphoma (FL), peripheral T-cell lymphoma (PTCL), natural killer/T-cell lymphoma (NKTCL), chronic lymphocytic leukaemia (CLL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL)
  • People with FL who have already been treated with at least two rounds of treatment, including a CD20 antibody therapy and at least one chemotherapy drug from the alkylating agent group (such as bendamustine or cyclophosphamide)
  • People with PTCL who have already had at least one round of treatment and whose disease has continued to grow or has not responded adequately; specific subtypes are eligible (confirm with trial site), and those with a subtype called ALCL must have previously received a CD30-targeted therapy or been assessed as unsuitable for it
  • People with NKTCL who have already had at least one round of treatment and whose disease has not responded or has progressed, and who have previously received a treatment containing a medicine called Pegaspargase or L-Pegaspargase
  • People with CLL who have measurable signs of disease (such as high levels of certain white blood cells in the blood, enlarged lymph nodes, or an enlarged liver or spleen caused by CLL), who have already received at least one round of treatment including specific targeted medicines (BTK inhibitors or BCL-2 inhibitors) and whose disease has not responded or who could not tolerate those treatments, and who currently meet the accepted medical guidelines for needing treatment
  • People with MZL who have already received at least two rounds of treatment including a CD20 antibody therapy, whose disease has not responded adequately to the most recent treatment or has progressed after treatment, and where the treating doctor considers that no effective standard treatment options remain
  • People with MCL who have already received at least two rounds of treatment including a CD20 antibody therapy (with or without a BTK inhibitor), and who have also been treated with at least one BTK inhibitor and one BCL-2 inhibitor
  • People who have a general health and activity level rated 0 to 2 on a standard medical scale (meaning able to carry out daily activities, possibly with some limitations)
  • People with an expected survival of at least 3 months
  • People whose heart, liver, kidneys, and other major organs are functioning adequately (confirm specific requirements with trial site)
  • People who have finished any prior cancer treatment (including radiation, chemotherapy, hormone therapy, surgery, or targeted therapy) at least 28 days before joining, or for a period based on how long the drug stays in the body — whichever is shorter
  • People who are able to have children and are willing to use effective contraception throughout the study and for six months after the last dose
  • People who voluntarily agree to take part and are willing and able to follow all trial procedures, confirmed by signing a consent form

Who may not be able to join:

  • People whose cancer has previously worsened while being treated with a type of drug called a PI3K inhibitor
  • People who have received any other cancer treatment within the 4 weeks before joining
  • People who have uncontrolled fluid build-up in body cavities (such as large amounts of fluid around the lungs or in the abdomen) that cannot be managed by draining
  • People whose cancer has spread to the brain or the lining around the brain
  • People who require long-term use of steroid medicines at a dose higher than the equivalent of 30mg per day of prednisone
  • People who are unable to swallow, or who have ongoing diarrhoea, a bowel blockage, or any other condition that would affect the ability to take or absorb the study medication
  • People with a known allergy or sensitivity to any component of the study treatment
  • People with a history of heart conditions, including chest pain (angina), irregular heartbeat requiring treatment, heart attack, heart failure, or any other heart condition considered unsuitable by the treating doctor
  • People with an active infection (such as pneumonia) caused by a virus, bacteria, or fungus that is currently being treated
  • People with uncontrolled diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, or liver failure
  • People with active hepatitis B (detected by specific blood markers and measurable virus levels) or active hepatitis C infection
  • People with a history of immune system deficiency, a positive HIV test, other inherited or acquired immune conditions, a history of organ transplant, or a history of bone marrow or stem cell transplant from a donor
  • People who have had their own stem cells transplanted (autologous transplant) within the 90 days before starting the study treatment
  • People who are unable to receive preventive treatment for certain infections (pneumocystis, HSV, or HZV) at the time of screening
  • People who have had major surgery within 2 weeks before starting treatment
  • People who still have side effects from previous treatments that have not recovered to a mild level (grade 1 or lower on a standard medical scale)
  • People with active bleeding, a new blood clot condition, or a history of bleeding problems
  • People who are pregnant or breastfeeding, or women of childbearing potential who have a positive pregnancy test at the start of the study
  • People with certain other serious ongoing health conditions such as severe high blood pressure, diabetes, or thyroid disease (confirm specific thresholds with trial site)
  • People who have had another type of cancer in the past 5 years, except for certain fully cured skin cancers or cervical carcinoma in situ
  • People who have received a live vaccine within 30 days before starting the study treatment
  • People diagnosed with grade 3b follicular lymphoma, or follicular lymphoma that has transformed into a type called diffuse large B-cell lymphoma
  • People with T-cell or NK/T-cell lymphoma who also have a serious complication called hemophagocytic syndrome
  • People considered unsuitable for the trial for any other reason, as assessed by the treating doctor

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 23 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.

Contact this trial

Phone: +86-13813810650

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 2
Registry
ClinicalTrials.gov
Start date
31 December 2024
Est. completion
31 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Best 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: 23 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