Actively Recruiting
Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR) for the Treatment of Untreated Follicular Lymphoma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-05-13
34
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR) for the Treatment of Untreated Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender.
- Histologically confirmed CD20-positive follicular lymphoma, Grade 1, 2, or 3A.
- Disease stage III or IV, or Stage II with bulky disease.
- Presence of at least one disease-related symptom or condition such as bulky tumor 7 cm, local symptoms or organ dysfunction, B symptoms, symptomatic extranodal involvement, cytopenias, involvement of 3 lymph nodes 3 cm, or symptomatic splenomegaly.
- No prior systemic therapy for follicular lymphoma.
- ECOG performance status of 0, 1, or 2.
- At least one measurable lesion larger than 2 cm by CT or MRI.
- Expected life expectancy of 6 months or more.
- Adequate organ function including neutrophil count 1.0x109/L without growth factors, platelets 50x109/L without recent transfusion, total bilirubin 1.5 times upper limit of normal, ALT/AST 3 times upper limit of normal, and creatinine clearance 30 mL/min.
- Men and women of childbearing potential must agree to use effective contraception during and for 4 weeks after treatment.
- Voluntary informed consent provided.
You will not qualify if you...
- Histologic evidence of central nervous system lymphoma, leptomeningeal lymphoma, or transformation to high-grade lymphoma.
- Grade 3B follicular lymphoma or transformed follicular lymphoma.
- Ann Arbor Stage I follicular lymphoma.
- Prior history of other malignancies unless disease-free for 5 years and low risk of recurrence.
- Use of investigational drugs, antibiotics, or participation in other interventional trials within 4 weeks before enrollment.
- Major surgery within 14 days before enrollment or planned during the study.
- Prior treatment with zanubrutinib, obinutuzumab, or lenalidomide.
- Immunodeficiency, autoimmune disease, or use of chronic systemic steroids or immunosuppressants within 7 days before enrollment.
- Severe liver dysfunction or multi-organ failure with kidney impairment.
- Significant cardiovascular disease including advanced heart failure, recent heart attack, malignant arrhythmias, uncontrolled hypertension, or unstable angina.
- Active infections including HIV or active hepatitis B/C with detectable virus.
- Uncontrolled systemic infections.
- Bleeding or clotting disorders or thrombotic events within 3 months.
- Severe allergies to study drugs.
- Pregnancy, breastfeeding, or unwillingness to use contraception if applicable.
- Other conditions deemed unsuitable by the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, Tianjin 300020
Tianjin, Tianjin Municipality, China, 300020
Not Yet Recruiting
2
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
S
Shuhua Yi, Dr
CONTACT
R
Rui Lyu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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