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

NCT ID: NCT04460248

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-26
• Study Completion Date: 2025-12-01

Brief Summary

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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zanubrutinib, Lenalidomide and Rituximab (ZR2)

Group Type: EXPERIMENTAL

Zanubrutinib, Lenalidomide and Rituximab (ZR2)

Intervention Type: DRUG

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:

1. Zanubrutinib, 160 mg bid, po, day 1-21;

2. Lenalidomide, 25 mg qd, po, day 2-11;

3. 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.

Interventions

Zanubrutinib, Lenalidomide and Rituximab (ZR2)

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:

1. Zanubrutinib, 160 mg bid, po, day 1-21;

2. Lenalidomide, 25 mg qd, po, day 2-11;

3. 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Treatment-naive pathologically confirmed patients with diffuse large B-cell lymphoma (DLBCL)
• Refuse to undergo systemic chemotherapy or not suitable for chemotherapy
• 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-tumor 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):

1. Neutrophils<1.5 x 10^9/L

2. Platelets<80 x 10^9/L

3. ALT or AST is 2 times higher than the normal upper limit, AKP and bilirubin are 1.5 times higher than normal upper limit

4. 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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

First Deputy Director of Shanghai Institute of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ZR2

Identifier Type: -

Identifier Source: org_study_id