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Efficacy and safety of Zuberitamb combined with bendamustine alternating Zuberitamab combined with high-dose cytarabine first-line induction therapy for mantle cell lymphoma: a prospective, multicenter, single-arm clinical study

Efficacy and safety of Zuberitamb combined with bendamustine alternating Zuberitamab combined with high-dose cytarabine first-line induction therapy for mantle cell lymphoma: a prospective, multicenter, single-arm clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096149
Enrollment
Unknown
Registered
2025-01-20
Start date
2025-01-27
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Mantle cell lymphoma

Interventions

Experimental group:Zuberitamb plus bendamustine or high-dose cytarabine

Sponsors

Second Affliated Hospital of Army Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects voluntarily join this study and sign the informed consent form; 2. Age>=18 years old, and = 3 months; 9. Cardiac color ultrasound: left ventricular ejection fraction >=50%; 10. Subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.

Exclusion criteria

Exclusion criteria: 1. The pathology is blast-like or pleomorphic variant MCL; 2. Patients with TP53 mutation or CDNK2A deletion confirmed by immunohistochemistry or FISH; 3. Received systemic or local therapy including chemotherapy within three weeks prior to enrollment; 4. Accompanied by other malignant tumors that require treatment or affect survival; 5. Clinically significant cardiac disease; 6. Patients who underwent major surgery within 4 weeks before enrollment; 7. Abnormal digestive tract function, such as gastric resection, intestinal resection, inflammatory bowel disease, etc.; 8. Chronic or active infectious diseases requiring systemic antibiotic, antifungal or antiviral therapy; 9. Concomitant treatment with anticoagulant drugs, or strong CYP3A4/5 inhibitors/inducers; 10. HBsAg positive; or HBsAg-negative but HBcAb-positive and HBV-DNA copy number above the upper limit of normal for detection; HCV antibody positive, and HCV-RNA copy number higher than the normal limit of the detection value; 11. HIV-infected people; 12. Central nervous system involvement; 13. Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, will affect the subject's participation in the study. Psychiatric patients or other subjects with known or suspected inability to fully comply with the study protocol; 14. Subjects judged by the investigator to be unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Complete response rate;

Secondary

MeasureTime frame
Overall response rate;Progression free survival;Event free survival;Duration of response;Overall survival;Safety;Treatment model and corresponding patient demographic and clinical characteristics;

Countries

China

Contacts

Public ContactXi Zhang

Second Affliated Hospital of Army Medical University, PLA

zhangxxi@sina.com+86 23 6875 5744

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026