Follicular Lymphoma Clinical Trials

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A Prospective, Open-label, Single-arm Multicenter Clinical Study of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Untreated Follicular Lymphoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, Tianjin 300020
NOT_YET_RECRUITING
Tianjin
Contact Information
Primary
Shuhua Yi, Dr
yishuhua@ihcams.ac.cn
+86-022-23909106
Backup
Rui Lyu
lvrui@ihcams.ac.cn
+86-022-23909106
Time Frame
Start Date: 2025-12-25
Estimated Completion Date: 2030-12-25
Participants
Target number of participants: 34
Treatments
Experimental: Experimental: Induction therapy of ZGR, and maintenance therapy of ZR
Induction therapy: All enrolled patients received the ZGR regimen (zanubrutinib, obinutuzumab, and lenalidomide) for Cycles 1-4. Tumor response was assessed after Cycle 4. Patients achieving complete response (CR) or partial response (PR) continued the same ZGR regimen for 2 additional cycles (Cycles 5-6).~Maintenance therapy: After completing induction therapy, patients with sustained CR/PR initiated maintenance therapy with zanubrutinib plus lenalidomide (ZR) for 18 months (1.5 years) or until disease progression, intolerable toxicity, or trial withdrawal (whichever occurred first)
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov