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

NCT04460248 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ZR2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcomes (3)

• 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.

Other Outcomes (1)

• Single-cell ribonucleic acid (scRNA) sequencing

  From enrollment to study completion, a maximum of 3 years.

Study Arms (1)

Zanubrutinib, Lenalidomide and Rituximab (ZR2)

EXPERIMENTAL

Drug: Zanubrutinib, Lenalidomide and Rituximab (ZR2)

Interventions

Zanubrutinib, Lenalidomide and Rituximab (ZR2) 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.

Zanubrutinib, Lenalidomide and Rituximab (ZR2)

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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):
• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• Xu PP, Zhu Y, Shi ZY, Wang L, Cheng S, Qian Y, Zhao Y, He Y, Yi HM, Ou-Yang BS, Jiang XF, Li B, Song Q, Mu RJ, Zhao WL. A phase 2 study of zanubrutinib in combination with rituximab and lenalidomide in de novo diffuse large B-cell lymphoma. Blood. 2025 Nov 20;146(21):2561-2573. doi: 10.1182/blood.2025028649.

  PMID: 40829156 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

zanubrutinib; Lenalidomide; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director of Shanghai Institute of Hematology

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 7, 2020
• Study Start: August 26, 2020
• Primary Completion: February 16, 2022
• Study Completion: December 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)