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NCT Number: NCT06503263

Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL

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.

Recruiting

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

Location status: Recruiting

Location contact

Liren Qian, M.D.

CONTACT

[email protected]

+861066947194

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Zanubrutinib plus Lenalidomide

Primary outcomes

  1. 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.

Secondary outcomes

  1. PFS

    Time frame: 2 years

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

  2. OS

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Liren Qian, PhD

CONTACT

[email protected]

+861066947192

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jul 16, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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