Fact CheckerSign in

NCT04436107CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 23 May 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
66 (actual)
First submitted
16 Jun 2020
Start date
11 Sept 2020
Primary completion date
28 Mar 2024
Lead sponsor
BeiGene
NCT number
NCT04436107

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 66
  • From 11 Sept 2020 to the primary completion date, 28 Mar 2024
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior exposure to a BTK inhibitor.
  • Prior exposure to lenalidomide or thalidomide.
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Other illness

  • Current or history of central nervous system (CNS) lymphoma.
  • History of allogeneic stem-cell transplantation.

Other

  • Histologically transformed lymphoma.

Who the study is looking for

  • Histologically confirmed DLBCL, all participants must provide sufficient archival or fresh tumor tissue samples for evaluation by immunohistochemistry (IHC) and Gene Expression Profiling (GEP).
  • 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.
  • Participants who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.
  • 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.
  • 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..

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Friendship Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Jilin Cancer Hospital
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Shanghai East Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Henan Cancer Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.