Gene-Guided cocktail aims to outsmart tough lymphoma
NCT ID NCT06803693
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding drugs tailored to a patient's tumor genetics can improve standard chemotherapy for untreated diffuse large B-cell lymphoma. About 152 adults with intermediate-to-high risk disease will receive either the standard Pola-RCHP regimen or a version with extra targeted agents. The main goal is to see if the personalized combo delays cancer progression or relapse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, prednisone, and genotype-guided targeted agents
- What this could lead to
- If successful, this could lead to a more personalized treatment approach for DLBCL, potentially improving how long patients stay cancer-free.
- What could go wrong
- This is a phase 2 trial with only 152 participants, so results are preliminary. The added drugs may increase side effects without clear benefit, and the approach may not work for all genetic subtypes.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 152 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Signed Informed Consent Form * Age 18-75 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures * Previously untreated participants with CD20-positive DLBCL * IPI score 2-5 * ECOG Performance Status of 0, 1, or 2 * After 1 cycle of Pola-R-CHP, ctDNA decreased by \< 3.0 LFC * Life expectancy ≥ 6 months * Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) * Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by DLBCL per the investigator for which blood product transfusions are permitted) defined as follows: * Hemoglobin ≥ 9.0 g/dL without packed RBC transfusion during 7 days before first treatment * ANC ≥ 1.0 x 10\^9/L * PLT ≥ 75 x 10\^9/L Exclusion Criteria: * Contraindication to any of the individual components of Pola-RCHP or Zanubrutinib/Lenalidomide/ Decitabine * Prior solid organ transplantation or SCT * Current diagnosis of the following: Follicular lymphoma grade 3B; mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; PCNSL * 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): * 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 Pola-RCHP-X * 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Ruijin Hospital, Shanghai JiaoTong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 200025, China
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