Clinical trial of Zanubrutinib With Obinutuzumab as First-Line Treatment in Older Patients With Mantle Cell Lymphoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300071433

Enrollment

Unknown

Registered

2023-05-15

Start date

2023-06-01

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle Cell Lymphoma

Interventions

Zanubrutinib with Obinutuzumab:Zanubrutinib with Obinutuzumab

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Pathology confirmed diagnosis of mantle cell lymphoma; 2. Age >= 65 years, regardless of gender; 3. ECOG score 0-3; 4. Measurable lesions or bone marrow/gastrointestinal involvement; 5. Serum bilirubin 30mL/min; 7. Obtained informed consent from patients or their family members.

Exclusion criteria

Exclusion criteria: 1. Blastoid or pleomorphic mantle cell lymphoma; 2. Received systemic or local treatment including chemotherapy within three weeks before enrollment; 3. Concurrent malignant tumors that require treatment or affect survival; 4. Heart disease with Clinical significant; 5. Expected survival period <3 months; 6. Active bleeding, history of severe bleeding or stroke within 6 months of first dose of study drug; 7. Patients who underwent major surgery within 4 weeks; 8. Abnormal gastrointestinal function, such as subtotal gastrectomy, intestinal resection, inflammatory bowel disease, etc; 9. Chronic or active infectious diseases requiring systemic antibiotics, antifungal drugs or antiviral therapy; 10. Patients who need to use anticoagulant drugs or receive strong CYP3A4/5 inhibitors or inducers; 11. HIV-infected patients; 12. Central nervous system involvement; 13. Other concurrent and uncontrollable medical conditions that the investigator believes will affect the patients' study participation. Patients with mental illness or other known or suspected patients who cannot fully comply with the study plan.

Design outcomes

Primary

Measure	Time frame
Complete Response Rate;	—

Secondary

Measure	Time frame
Overall Response Rate;Progression Free Survival;Overall Survival;Minimal Residual Disease;	—

Countries

China

Contacts

Public ContactWenjuan Yu

The First Affiliated Hospital of Zhejiang University Medical College

drwjyu@163.com+86 137 5085 3563

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026