Diffuse Large B-cell Lymphoma
Conditions
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 planed courses of chemotherapy . Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.
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
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EFS | 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
| Measure | Time frame | Description |
|---|---|---|
| PFS | 2 years | PFS was defined as the time from study entry until disease progression or death by any cause |
| OS | 2 years | OS was defined as the time from treatment initiation to death by any cause. |
Countries
China
Contacts
Primary ContactLiren Qian, PhD
Outcome results
None listed