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New treatment option for Follicular Lymphoma
Official title Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR) for the Treatment of Untreated Follicular Lymphoma
ClinicalTrials.gov ID: NCT07299149
What this study is testing
What is Induction Therapy: Zanubrutinib, obinutuzumab, lenalidomide?
Induction Therapy: Zanubrutinib, obinutuzumab, lenalidomide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for follicular lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is planned to prospectively evaluates the efficacy and safety of the zanubrutinib, obinutuzumab, and lenalidomide (ZGR) combination regimen in treatment-naïve follicular lymphoma (FL) patients in a Chinese population.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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...
- Use of any investigational drugs, antibiotics, or participation in another treatment clinical trial within 4 weeks prior to enrollment.
See the full eligibility 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...
- 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).
- 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...
- Use of any investigational drugs, antibiotics, or participation in another treatment 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.