NCT07206264

Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Mantle cell lymphoma (MCL) is a subtype of B-cell non-Hodgkin's lymphoma and is considered to be incurable. MCL patients have varied clinical presentations (generally symptomatic to an asymptomatic indolent clinical course). Over the past decade, significant advances in the treatment of MCL have been achieved through intensive immunochemotherapy regimens and clinical trials evaluating novel targeted agents and combination strategies. However, early disease relapse remains a frequent clinical challenge. Recently, combination regimens involving chemotherapy and targeted therapy have demonstrated promising efficacy with acceptable safety profiles. Bendamustine is a unique cytotoxic agent that induces apoptosis through activation of DNA damage stress responses, disruption of mitotic checkpoints, and induction of mitotic catastrophe. Zuberitamab is a novel anti-CD20 monoclonal antibody that demonstrates enhanced antibody-dependent cellular cytotoxicity compared with rituximab. Orelabrutinib is a potent, irreversible, and highly selective Bruton tyrosine kinase inhibitor. This study is a multicenter, prospective trial involving previously untreated patients with MCL. During the induction phase (cycles 1-4), all patients will receive bendamustine at a dose of 90 mg/m² in combination with anti-CD20 monoclonal antibody at 375 mg/m². After cycle 4, patients who achieve a complete response (CR) and are minimal residual disease (MRD) negative will continue to receive the same regimen (bendamustine 90 mg/m² plus anti-CD20 monoclonal antibody 375mg/m²) for cycles 5 to 6. In contrast, patients who are MRD positive will switch to a treatment regimen consisting of orelabrutinib at 150 mg combined with anti-CD20 monoclonal antibody at 375 mg/m². During the maintenance phase (cycles 7-24), patients who achieve CR and are MRD negative at cycle 4 will continue receiving bendamustine plus anti-CD20 monoclonal antibody, while MRD-positive patients will continue treatment with orelabrutinib plus anti-CD20 monoclonal antibody until disease progression, relapse, intolerable toxicities, death, loss to follow-up, or withdrawal of consent, whichever occurs first, with a maximum of 24 cycles.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

5 sites across 1 country: China