Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL

July 10, 2024 updated by: Liren Qian, Navy General Hospital, Beijing

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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