NCT05527912

A Phase II Study of Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy

A Single-arm、Multicenter、Open-label、Phase II Clinical Study of the Combination of Rituximab、Chidamide、Zanubrutinib-induced and CHOP Therapy for Untreated Dual-expressing Diffuse Large B Cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well giving rituximab,chidamide, and zanubrutinib with Sequential chemotherapy works in treating patients with double express diffuse large B-cell lymphoma. The prognosis of patients with DEL-DLBCL is usually worse than that of ordinary DLBCL.

Conditions

• Double Express Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy	All subjects received two courses of the following treatment: Rituximab ，375mg/m²， D1； Chidamiade ，20mg ，biw， d1-14； Zanubrutinib ，160mg， bid， d1-21； three weeks for a period of treatment, all subjects complete tumor assessment after two courses of treatment, patients which achieve complete remission continue for up to 8 sessions, patients achieve partial response and stable disease combined use of the following CHOP threapy to 6 courses, Patients with progressive disease dropped out of this research. CHOP Therapy: Cyclophosphamide， 750mg/m² ，D1； Vincristine， 1.4mg/m² ，D1 (maximum：2mg)； Doxorubicin or pirarubicin， 50mg/m²， D1； Prednisone ，30mg ，tid， D1-5.

Timeline

• Start date: 2023-02-24
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2022-09-06
• Last updated: 2023-04-25

Locations

2 sites across 1 country: China