AI takes on lymphoma: personalized treatment strategy under trial

NCT ID NCT07594899

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares an AI-driven treatment strategy to standard therapy (Pola-R-CHP) for people with previously untreated large B-cell lymphoma. About 178 participants will be grouped by risk using an AI model, and those at intermediate or high risk will receive either a personalized treatment (based on genetics or an additional drug) or standard care. The goal is to see if the AI-guided approach improves how long people live without their cancer coming back.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 178 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-75 years with comprehensive geriatric assessment stratified as fit * Previously untreated participants with CD20-positive LBCL (without central nervous system involvement) * ECOG Performance Status of 0, 1, or 2 * After 1 cycle of Pola-R-CHP, classified as intermediate-risk or high-risk by AI-based multimodal stratification * Life expectancy ≥ 3 months * At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters) * The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research. * Anti-lymphoma drugs have not been used before (except glucocorticoids) Exclusion Criteria: * Prior solid organ transplantation or SCT * Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina * History or presence of an abnormal ECG that is clinically significant in the investigator's opinion * Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma): * Absolute neutrophil count \<1.0 × 10⁹/L. * Platelet count \<75 × 10⁹/L * Serum AST and ALT ≥ 2.5 x ULN * Total bilirubin ≥ 1.5 x ULN * Serum creatinine clearance \< 30 mL/min (using Cockcroft-Gault formula) * Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety * Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology):Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HbsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing every month and appropriate antiviral therapy as indicated * Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing):Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA * Participants with a history of progressive multifocal leukoencephalopathy * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of treatment * Participants with uncontrolled coagulation disorders, connective tissue diseases, severe infectious diseases * Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's participation in the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200020, China

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