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Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study of Bruton Tyrosine Kinase (BTK) Inhibitor, Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04436107•BeiGene

View on ClinicalTrials.gov

Summary

The primary objective of this study is to determine the maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D), and safety, tolerability, and efficacy of zanubrutinib in combination with lenalidomide in participants with R/R DLBCL

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed DLBCL, all participants must provide sufficient archival or fresh tumor tissue samples for evaluation by immunohistochemistry (IHC) and Gene Expression Profiling (GEP).
•2. Relapsed or refractory disease, defined as either: 1) progression of disease after having achieved disease remission (complete response \[CR\] or partial response \[PR\]) , or 2) stable disease (SD), or progressive disease (PD) at completion of the treatment regimen preceding entry to the study.
•3. Participants who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.
•4. Measurable disease as defined by at least 1 lymph node \>1.5 cm in longest diameter, or at least 1 extra-nodal lesion \>1.0 cm in longest diameter, and measurable in 2 perpendicular dimensions.
•5. Received an appropriate first-line therapy for DLBCL,defined as an anti CD20 antibody and an appropriate anthracycline-based combination therapy for at least 2 cycles, unless the patient is intolerant or had disease progression before Cycle 2..

Exclusion Criteria

•1. Current or history of central nervous system (CNS) lymphoma.
•2. Histologically transformed lymphoma.
•3. History of allogeneic stem-cell transplantation.
•4. Prior exposure to a BTK inhibitor.
•5. Prior exposure to lenalidomide or thalidomide.

Locations (10)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Jilin Cancer Hospital

Changchun, Jilin, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Key Dates

Start Date

September 11, 2020

Primary Completion Date

March 28, 2024

Completion Date

March 28, 2024

Last Updated

May 23, 2025

Enrollment

ACTUAL participants

Conditions

Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Interventions

Zanubrutinib

DRUG

Lenalidomide

DRUG