New drug cocktail aims to boost lymphoma remission
NCT ID NCT07505849
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding zanubrutinib to the standard R2 regimen (rituximab and lenalidomide) improves outcomes for adults with newly diagnosed follicular lymphoma. About 100 participants will be randomly assigned to receive either the new ZR2 combo or standard R2, followed by maintenance therapy. The main goal is to see if more patients achieve complete remission with the new combination.
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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: 1. Voluntarily participate in the clinical study; fully understand and comprehend this study and sign the Informed Consent Form (ICF); willing to follow and capable of completing all study steps; 2. According to the 5th edition of the WHO classification of hematological and lymphoid tumors, diagnosed as CD20+ classic FL (grade 1-3a FL) by histology, and no previous anti-FL treatment has been received; 3. Age ≥ 18 years; 4. Judged by the investigator, the subject must urgently need to receive systemic treatment, based on meeting at least one GELF criterion; 5. At least one measurable lesion \[longest diameter (LDi) ≥ 15mm, lymph node lesion LDi ≥ 10mm, evaluated according to the 2014 Lugano efficacy criteria\]; 6. The subject has at least one measurable target lesion: i. PET/CT scan shows positive PET lesion, or ii. CT scan or MRI shows \> 1 measurable lymph node lesion (long axis \> 1.5 cm) or \> 1 measurable extranodal lesion (long axis \> 1.0 cm); 7. ECOG performance status is 0-2; 8. Expected survival period \> 3 months; 9. Adequate organ function and bone marrow function, without severe heart, lung, liver, kidney and immune deficiencies (no blood transfusion, granulocyte colony-stimulating factor or other medical support drugs within 7 days before starting this study): hemoglobin (HB) ≥ 60 g/L; absolute neutrophil count (ANC) ≥ 5×109/L; platelets (PLT) ≥ 50×109/L; aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 5×ULN; total bilirubin (TBIL) ≤ 1.5×ULN; creatinine clearance rate (Ccr) ≥ 40 ml/min (estimated by Cockcroft-Gault formula); left ventricular ejection fraction (LVEF) ≥ lower limit of normal value. 10. Patients with reproductive potential must agree to use effective contraceptive measures (dual methods, such as condom + oral contraceptive), and avoid pregnancy or make their partners pregnant during the treatment period and within 12 months after the last administration. Exclusion Criteria: 1. The subject has a history of systemic anti-leukemia treatment for FL (including any curative radiotherapy for the purpose of cure); 2. The subject has a history of aggressive B-cell lymphoma or has currently undergone histological transformation to DLBCL; 3. FL 3b; 4. The subject had suspected or confirmed primary CNS tumor at screening or had evidence of known CNS involvement; 5. The subject has a history of severe allergic reaction or immediate severe allergic reaction to any component or excipient of zanubrutinib, lenalidomide, or rituximab; 6. Has other tumors that affect the study medication or interfere with the results; 7. Received live vaccine within 28 days before treatment; 8. Has reproductive capacity and is unwilling to use effective contraceptive measures; 9. Pregnant or lactating women; 10. Known human immunodeficiency virus (HIV) infection, or any serological status indicating active hepatitis B or hepatitis C virus infection: 1) HBV DNA positive. Positive for hepatitis B surface antigen (HBsAg) or serologically positive for hepatitis B core antibody (HBcAb), if HBV DNA is undetectable and is willing to undergo monthly HBV reactivation monitoring, then can be enrolled. 2) HCV antibody positive. For patients with HCV antibody, if HCV RNA is undetectable, then can be enrolled; 11. Severe coagulation disorders and severe damage to organs such as heart, brain, lungs, liver, and kidneys; 12. Had a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months; has any life-threatening disease, medical condition, or organ system dysfunction that the subject considers may affect the safety of the subject or cause study risks.
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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 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.