RecruitingPhase 2NCT06503263

Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL

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


Sponsor

Navy General Hospital, Beijing

Enrollment

240 participants

Start Date

Aug 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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

Interventions

DRUGZanubrutinib plus Lenalidomide as Maintenance Therapy

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


Locations(1)

Navy General Hospital

Beijing, Beijing Municipality, China

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NCT06503263


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