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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06503263
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