Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL

Zanubrutinib and Lenalidomide as Maintenance Therapy in Patients With Diffuse Large B-cell Lymphoma

The goal of this phase 2 trial is to test the safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with DLBCL.

Study Overview

• Status: Not yet recruiting
• Conditions: Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Drug: Zanubrutinib plus Lenalidomide as Maintenance Therapy

Detailed Description

The investigators will evaluate safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with diffuse large B-cell lymphoma post complete remission and have completed planed courses of chemotherapy . Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liren Qian, PhD; Phone Number: +861066947192; Email: qlr2007@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100048
      • Navy General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
• Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
• Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
• Patient has recieved complete remission and has completed planed courses of chemotherapy
• Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10^9/L (≥ 1 x 10^9/L if bone marrow (BM) involvement by lymphoma)；Platelet ≥ 75 x 10^9/L (≥ 50 x 10^9/L if BM involvement by lymphoma)； Hemoglobin ≥ 8 g/dL. Anticipated life expectancy at least 3 months

Exclusion Criteria:

• Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
• Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maintenance Therapy; Patients were treated by Zanubrutinib plus Lenalidomide as Maintenance Therapy	Drug: Zanubrutinib plus Lenalidomide as Maintenance Therapy; Patients were treated by Zanubrutinib(160mg po bid d1-28) plus Lenalidomide(25mg po qd d1-21) as maintenance therapy until 2 years post chemotherpay; Other Names: Zanubrutinib plus Lenalidomide
No Intervention: No maintenance Therapy; Patients received no maintenance Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EFS	EFS was defined as the time from treatment initiation to progression, relapse, new treatment, or death by any cause, whichever occurred first.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	PFS was defined as the time from study entry until disease progression or death by any cause	2 years
OS	OS was defined as the time from treatment initiation to death by any cause.	2 years

Collaborators and Investigators

• Sponsor: Navy General Hospital, Beijing
• Investigators: Principal Investigator: qlr2007@126.com Qian, PhD, Navy General Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2024
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Lenalidomide; Zanubrutinib
• Other Study ID Numbers: ZLDLBCL2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No