Zanubrutinib, Lenalidomide and Rituximab (ZR2) in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)

Study Overview
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Brief Summary
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This is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) regimen in elderly treatment-naive patient with diffuse large B-cell lymphomas.

Official Title
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The Efficacy and Safety of Zanubrutinib, Lenalidomide and Rituximab (ZR2) Regimen in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: Zanubrutinib, Lenalidomide and Rituximab (ZR2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment-naive pathologically confirmed patients with diffuse large B-cell lymphoma (DLBCL) Reluctant to undergo systemic chemotherapy or not suitable for chemotherapy defined as ECOG>2, ADL<100 or CCI>1 Radiography detects measurable lesions defined as at least 1 clearly defined lesion/nodule with both long and short diameters longer than or equal to 1.5cm Life expectancy of at least 3 months determined by researchers The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research Research drugs have not been used before Exclusion Criteria: The patient has received systemic or local anti-lymphoma treatment, including chemotherapy, within three weeks before enrollment The patient has complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases Laboratory measures meet the following criteria at screening (unless caused by lymphoma): Neutrophils<1.5 x 10^9/L Platelets<80 x 10^9/L ALT or AST is 2 times higher than the normal upper limit, AKP and bilirubin are 1.5 times higher than normal upper limit Creatinine is 1.5 times higher than the normal upper limit Other concurrent and uncontrolled medical conditions that the researchers believe that they will affect the patient's participation in the study, including patients with psychosis or other known or suspected patients who cannot fully comply with the research protocol HIV-infected patients Patients with HbsAg positive are required to have negative HBV DNA before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and if the result is positive, anti-viral treatment is also required, and negative HBV DNA is required before entering the group Other medical conditions determined by the researchers that may affect the study

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zanubrutinib, Lenalidomide and Rituximab (ZR2)<br> | Drug: Zanubrutinib, Lenalidomide and Rituximab (ZR2)<br>* Induction therapy: The ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles. Dosage: Zanubrutinib, 160 mg bid, po, day 1-21; Lenalidomide, 25 mg qd, po, day 2-11; Rituximab, 375 mg/m2, ivgtt, day 1. Maintenance therapy: Patients who receive complete response or partial response after induction therapy will receive lenalidomide 25 mg qd po during 1-10 days in every 21 days, for a maximum of 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | At the end of Cycle 6 (each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year progression-free survival |  | 2 years after enrollment | 
| 2-year overall survival |  | 2 years after enrollment | 
| Incidence rate of adverse events |  | From enrollment to study completion, a maximum of 3 years. |