As the most common subtype of lymphoma, diffuse large B-cell lymphoma (DLBCL) is an aggressive but potentially curable malignancy. The poor prognosis of elderly DLBCL patients may be related to the biological behavior of the disease, more comorbidities, poor performance status, and inability to tolerate standard-intensity immunochemotherapy. The investigators plan to use ZR2 regimen(rituximab, lenalidomide and zanubrutinib) for 2 cycles followed by immunochemotherapy for up to 4 cycles in elderly newly diagnosed DLBCL patients.
DLBCL mostly occurs in the elderly, with a median age at diagnosis of 66 years. Age over 60 years is a poor prognostic factor for DLBCL and is included in the International Prognostic Index (IPI) to stratify patients for prognosis. So there is an unmet need for treatment in this population. Both lenalidomide and BTK inhibitor single drugs have shown certain efficacy in DLBCL patients, and many studies have also explored the effectiveness of rituximab, lenalidomide and BTK inhibitor combination regimen in the treatment of DLBCL. Therefore, the investigators plan to use ZR2 regimen(rituximab, lenalidomide and zanubrutinib) for 2 cycles to reduce tumor burden, improve the patient's physical condition, and improve the tolerance to immunochemotherapy in elderly newly diagnosed DLBCL patients. Up to 4 cycles of immunochemotherapy were then administered sequentially in order to reduce the overall chemotherapy intensity of the patients and improve the long-term quality of life of the patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
chemo free period (21 days as a cycle, a total of 2 cycles): rituximab 375mg/m2, d1, lenalidomide 10mg qd d1-10, zanubrutinib 160mg bid. Immunochemotherapy period: RCHOP regimen (21 days as 1 cycle, a total of 4 cycles): rituximab 375mg/m2 d0, cyclophosphamide: 750mg/m2 d1, epirubicin: 75mg/m2 d1 (or liposomal doxorubicin 35mg/m2 d1), vindesine 4mg d1, prednisone: 100mg, d1-5.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGORR
overall response rate
Time frame: 21days after the end of treatment
PFS
Progression Free Survival
Time frame: From date of first day of treatment until the date of first documented progression, assessed up to 24 months
OS
Overall Survival
Time frame: From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months
AE and SAE
Adverse event and serious adverse event
Time frame: From date of first day of treatment until 30 day after last treatment
Performance status
Assess the patient's performance status according to the Barthel index. Patients will be classified into 5 scales with the score ranging from 0 to 100: 0-20 points=extremely severe functional impairment; 25-45 points=severe functional impairment; 50-70 points=moderate functional impairment; 75-95 points=mild functional impairment; 100 points=normal. Higher scores mean a better outcome.
Time frame: At screening period, after 2 cycles of ZR2 regimen(each cycle is 21 days), after 2 cycles of RCHOP regimen(each cycle is 21 days) and 21days after the end of treatment
Life quality
Assess the patient's quality of life according to the EORTC QLQ-C30 questionnaire. Higher scores mean a worse outcome.
Time frame: At screening period, after 2 cycles of ZR2 regimen(each cycle is 21 days), after 2 cycles of RCHOP regimen(each cycle is 21 days) and 21days after the end of treatment
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