Health TrialsbyHealthPanel

Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL

ConditionDiffuse Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorNavy General Hospital, Beijing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zanubrutinib plus Lenalidomide as Maintenance Therapy

    Drug

    Patients were treated by Zanubrutinib(160mg po bid d1-28) plus Lenalidomide(25mg po qd d1-14) as maintenance therapy until 2 years post chemotherpay

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Maintenance TherapyExperimental treatment 1 intervention
Group B: No maintenance TherapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

EFS

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

Time frame
2 years

Secondary outcomes

1

PFS

PFS was defined as the time from study entry until disease progression or death by any cause

Time frame
2 years
2

OS

OS was defined as the time from treatment initiation to death by any cause.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Navy General Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov
Apply now