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NOT YET RECRUITING
NCT07206264
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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