Status:
RECRUITING
Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL
Lead Sponsor:
Navy General Hospital, Beijing
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
14+ years
Phase:
PHASE2
Brief 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.
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2030
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06503263
Start Date
August 30 2024
End Date
December 30 2030
Last Update
September 19 2024
Active Locations (1)
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1
Navy General Hospital
Beijing, Beijing Municipality, China, 100048