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Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
This is a single-arm, multi-center, prospective, phase II study. The primary objective is to assess the efficacy and safety of bendamustine/orelabrutinib combined with an anti-CD20 monoclonal antibody in treatment-naïve patients with mantle cell lymphoma.
Official title: Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment: a Multi-center, Phase II Study
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-10
Completion Date
2028-12
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody
Induction phase (cycle 1-6): Bendamustine (90 mg/m², day 1-2) +anti-CD20 monoclonal antibody (375 mg/m², day 0) from cycles 1-4. Patients who achieve CR and MRD negative continue to receive bendamustine (90 mg/m², day 1-2) + anti-CD20 monoclonal antibody (375 mg/m², day 0) from cycles 5-6; MRD positive patients receive orelabrutinib (150 mg) + anti-CD20 monoclonal antibody (375 mg/m², day 0). Maintenance phase (cycle 7-24): Patients who achieve CR and are MRD negative at cycle 4 receive bendamustine (90 mg/m², day 1-2) + anti-CD20 monoclonal antibody (375 mg/m², day 0); MRD-positive patients receive orelabrutinib (150 mg) + anti-CD20 monoclonal antibody (375 mg/m², day 0).
Locations (5)
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Hebei Medical University Tumor Hospital
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Shandong Cancer Hospital
Jinan, Shandong, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China