Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR)...

About this study

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.

Condition: Follicular Lymphoma
Tested: Induction Therapy: Zanubrutinib, obinutuzumab, lenalidomide, Maintenance therapy: Zanubrutinib, lenalidomide
Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Who can join

Age: 18 to 90 years
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 26

Minimum age: 18 years
Maximum age: 90 years
Study condition: Follicular Lymphoma
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 20

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.

Where

2 sites, 2 recruiting

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Recruiting

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, Tianjin 300020