Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL

Phase 2

Not yet recruiting

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: Zanubrutinib plus Lenalidomide as Maintenance Therapy

• Registration Number: NCT06503263
• Lead Sponsor: Navy General Hospital, Beijing

Brief Summary

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.

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16
• Study Start: 2024-07-30
• Primary Completion: 2030-07-30
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maintenance Therapy	Zanubrutinib plus Lenalidomide as Maintenance Therapy	Patients were treated by Zanubrutinib plus Lenalidomide as Maintenance Therapy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Navy General Hospital; 🇨🇳 Beijing, Beijing, China