New drug cocktail aims to control follicular lymphoma without chemo
NCT ID NCT07299149
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs (zanubrutinib, obinutuzumab, and lenalidomide) in people with untreated follicular lymphoma, a slow-growing blood cancer. The goal is to see how well the combo shrinks or eliminates tumors. About 34 adults with stage II bulky or stage III/IV disease will take part. This is not a cure, but aims to control the disease long-term.
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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 34 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2030
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 90 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Gender: No restrictions; age ≥18 years. * Diagnosis: Histologically confirmed CD20-positive follicular lymphoma (FL), Grade 1, 2, or 3A, per 2016 WHO classification. All patients must provide sufficient archived or fresh tumor tissue samples for immunohistochemical (IHC) analysis. * Disease Stage \& Treatment Need: * Stage III or IV disease, or Stage II with bulky disease, meeting at least one of the following criteria: * a) Bulky disease: Lymph node or extranodal (excluding spleen) mass with maximum diameter ≥7 cm. * b) Local symptoms or organ dysfunction due to progressive lymphadenopathy or extranodal tumor mass. * c) B symptoms (fever, night sweats, or unintentional weight loss \>10% of body weight within ≤6 months). * d) Symptomatic extranodal involvement (e.g., pleural/peritoneal effusion). * e) Cytopenias due to bone marrow infiltration (hemoglobin \<10 g/dL, absolute neutrophil count \[ANC\] \<1.0×10⁹/L, platelets \<100×10⁹/L). * f) Involvement of ≥3 lymph nodes, each ≥3 cm in diameter. * g) Symptomatic splenomegaly. * Prior Therapy: No prior systemic therapy for FL. * ECOG Performance Status: ≤2. * Measurable Disease: At least one measurable lesion (\>2 cm in longest diameter by CT/MRI). * Life Expectancy: ≥6 months. * Adequate Organ Function: * a) ANC ≥1.0×10⁹/L (without growth factor support). * b) Platelets ≥50×10⁹/L (untransfused within 7 days). * c) Total bilirubin (TBIL) ≤1.5×ULN. * d) ALT/AST ≤3×ULN. * e) Creatinine clearance ≥30 mL/min (calculated by modified Cockcroft-Gault formula). * Contraception: Men and women of childbearing potential must agree to use highly effective contraception during the study and for 4 weeks after treatment discontinuation. * Informed Consent: Patients must voluntarily participate and sign informed consent forms (ICF). Exclusion Criteria: * Patients meeting any of the following criteria will be excluded from this study: * Histologic evidence of central nervous system (CNS) lymphoma, leptomeningeal lymphoma, or transformation to high-grade lymphoma (e.g., diffuse large B-cell lymphoma, DLBCL). * Grade 3B follicular lymphoma (FL) or transformed FL. * Ann Arbor Stage I FL. * Prior history of malignancy, unless the patient has been disease-free for ≥5 years and the treating physician deems the risk of recurrence low (exceptions: non-melanoma skin cancer, cured localized prostate cancer, carcinoma in situ of the cervix, or squamous intraepithelial lesions on PAP smear). * Use of any investigational drugs, antibiotics, or participation in another interventional clinical trial within 4 weeks prior to enrollment. * Major surgery (excluding lymph node biopsy) within 14 days before enrollment or anticipated need for major surgery during the study. * Prior treatment with zanubrutinib, obinutuzumab, or lenalidomide. * Immunodeficiency or autoimmune disease history, or chronic systemic steroid therapy (\>10 mg/day prednisone equivalent) or immunosuppressive therapy within 7 days before enrollment. * Severe hepatic dysfunction (including severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome), cachexia, or multi-organ failure with renal impairment. * Clinically significant cardiovascular abnormalities: * NYHA Class III/IV heart failure * Myocardial infarction within 6 months before enrollment, Malignant arrhythmias (including QTc ≥480 ms), Uncontrolled hypertension (Systolic blood pressure (SBP) ≥150 mmHg and diastolic blood pressure (DBP) ≥100 mmHg), Unstable angina. Active infections: * HIV, active hepatitis B/C infection (HBV DNA ≥2000 IU/mL or HCV RNA detectable) * Uncontrolled systemic infections. * Bleeding disorders or coagulation abnormalities, or thrombotic events within 3 months. * Severe hypersensitivity to the active ingredients or excipients of the study drugs. * Pregnancy, lactation, or unwillingness to use effective contraception in women of childbearing potential. * Other conditions deemed unsuitable by the investigator.
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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
2 sites. 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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Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
RECRUITINGTianjin, Tianjin Municipality, 300020, China
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Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, Tianjin 300020
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New antibody tested against aggressive blood cancer
- Can a new drug delay the need for lymphoma treatment?
- Can a single injection reprogram immune cells to fight cancer?
- Can a new immune cell therapy outsmart resistant blood cancers?
- Can a Triple-Drug combo wipe out Slow-Growing lymphomas?