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drugset / Trial / NCT05504603

Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma

NCT05504603 ↗

Phase 2 Unknown 20 enrolled The First Affiliated Hospital of Soochow University
NaSingle-groupOpen-labelTreatment

Summary

The proposed study is a prospective, single-center, single-arm and open-ended phase II study in patients over the age of 18 with previously untreated mantle cell lymphoma(MCL). The primary objective of this study is to explore the safety and efficacy of a new chemo-free treatment pattern zanubrutinib-rituximab(ZR) in newly diagnosed MCL.

Timeline

Start
2020-07-27
Primary completion
2023-07-26
Completion
2025-07-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Zanubrutinib Small molecule 160 mg Oral
Background Cytarabine Small molecule 400 mg/m2 Intravenous
Background Etoposide Small molecule 200 mg/m2 Intravenous
Background Melphalan Small molecule 140 mg/m2 Intravenous
Background Semustine Small molecule 250 mg/m2 Oral

Indications

mantle cell lymphoma