NCT05200312

A Phase II Study of Zanubrutinib, Lenalidomide Plus R-CHOP as the First-line Treatment for Diffused Large B-cell Lymphoma

A Phase II Study of the Bruton's Tyrosine Kinase Inhibitor, Zanubrutinib, in Combination With Lenalidomide Plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, open-label, single-arm, non-randomized phase II clinical study in order to evaluate the safety and efficacy of zanubrutinib, lenalidomide plus R-CHOP (ZR2-CHOP) as the first-line therapy for treatment-naive high-risk diffuse large B-cell lymphoma patients.

Conditions

• Non Hodgkin Lymphoma
• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Zanubrutinib	160 mg capsules administered by mouth twice daily (21-day cycles).
DRUG	Lenalidomide	25 mg capsules administered by mouth once daily on Day 1 to Day 10 of each cycle (21-day cycles)
DRUG	Rituximab	375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
DRUG	Cyclophosphamide	750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
DRUG	Doxorubicin	50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
DRUG	Vincristine	1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
DRUG	Prednisone (or equivalent)	40 mg/m2 capsules administered by mouth once daily on Day 1 to Day 5 of each cycle

Timeline

• Start date: 2022-02-01
• Primary completion: 2024-02-01
• Completion: 2025-02-01
• First posted: 2022-01-20
• Last updated: 2022-03-11

Locations

2 sites across 1 country: China