NCT05392257

Efficacy and Safety of Rituximab Plus Zanubrutinib and Lenalidomide for Relapsed and Refractory Diffuse Large B Cell Lymphoma, a Multicenter, Open and Prospective Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Qingdao Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is an investigator-initiated multicenter, open, prospective clinical study in order to explore the efficacy and safety of rituximab plus zanubrutinib and lenalidomide in relapsed and refractory diffuse large B cell lymphoma.

Detailed description

Subjects are patients withRelapsed and refractory Diffuse Large B cell lymphoma (DLBCL). All included patients will be treated with rituximab plus zanubrutinib and lenalidomide. In the induction stage, patients will receive 375 mg/m2 rituximab Day 1 of Cycles 1-6, twice-daily 160 mg zanubrutinib and 25 mg lenalidomide Days 1-21 of each 28-day cycle. In the maintenance treatment period, patients will receive 375 mg/m2 rituximab every 2 months, twice-daily 160 mg zanubrutinib and 10 mg lenalidomide Days 1-21 of each 28-day cycle. Imaging evaluation will take every two cycles to determine the best therapeutic effect, PD patients will exit from the clinical trial. The comprehensive therapeutic evaluating will take after 4 cycles. Peripheral blood stem cells can be collected from young patients with PR or CR. If patients' condition is suitable after 6 cycles of induction therapies, autologous hematopoietic stem cell transplantation can be chosed for patients with PR or CR and exit from the trail.Primary study endpoint is objective response rate (ORR) at the end of 6 cycles of induction therapy. Secondary study endpoints include progression-free survival time (PFS), overall survival (OS) and adverse reaction events (TEAS). After sample size calculation, we plan to enroll 72 relapsed and refractory diffuse large B cell lymphoma patients.

Conditions

• Overall Survival

Interventions

Type	Name	Description
DRUG	Rituximab + zanubrutinib + lenalidomide	Rituximab at 375mg / m2, Day 0; Zanubrutinib 160mg bid continuously oral; Lenalidomide 25mg qd oral on days 1-21; 28 days as a course of treatment

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2022-05-26
• Last updated: 2022-05-26

Locations

1 site across 1 country: China