Efficacy and Safety of Rituximab Plus Zanubrutinib and Lenalidomide for Relapsed and Refractory Diffuse Large B Cell Lymphoma, a Multicenter, Open and Prospective Clinical Trial

NCT05392257 | Unknown Phase 2

• 1 other identifier: QDCH20220521
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is an investigator-initiated multicenter, open, prospective clinical study in order to explore the efficacy and safety of rituximab plus zanubrutinib and lenalidomide in relapsed and refractory diffuse large B cell lymphoma.

Conditions

Overall Survival

Outcome Measures

Primary Outcomes (1)

• The overall survival in this population of patients

  The overall survival of the enrolled patients from start the combination treatment of Rituximab + zanubrutinib + lenalidomide regimen

  24 months

Secondary Outcomes (1)

• The progression free survival in this population of patients

  24 months

Study Arms (1)

Arms

EXPERIMENTAL

Drug: Rituximab + zanubrutinib + lenalidomide

Interventions

Rituximab + zanubrutinib + lenalidomide DRUG

Rituximab at 375mg / m2, Day 0; Zanubrutinib 160mg bid continuously oral; Lenalidomide 25mg qd oral on days 1-21; 28 days as a course of treatment

Arms

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ．Before starting treatment, two pregnancy tests (at least one of them should be a serological pregnancy test) should be performed and the result must be negative.The first test must be conducted within 10-14 days before lenalidomide treatment, and the second test should within 24 hours before lenalidomide treatment.
• ．Fertile women must agree to use reliable contraception from 4 weeks before lenalidomide treatment to at least 90 days after the last administration of zanubrutinib and lenalidomide, or 12 months after the last administration of rituximab (whichever is longer as the standard). Male patients taking the study drug may not donate sperm throughout the study.
• ．Patients are not allowed to donate blood during lenalidomide treatment and within 4weeks after withdrawal, as blood may be used in pregnant female patients whose fetus will not be exposed to lenalidomide.

You may not qualify if:

• ．Have clinically significant cardiovascular disease, including: 1) myocardial infarction that occurred within 6 months prior to screening stage; 2) Unstable angina pectoris within 3 months before screening stage; 3) Clinical major arrhythmia (e.g., persistent ventricular tachycardia, ventricular fibrillation, tachycardia with torsional tip); 4) QTcF (corrected according to Fridericia formula) \>480 msec; 5) History of second-degree type II atrioventricular block or third-degree ATrioventricular block; 6) Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA).
• ．History of severe hemorrhagic disease, such as hemophilia A, hemophilia B, von willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
• ．History of stroke or intracranial hemorrhage within 6 months prior to the first taking of the investigational drug.
• ．Inability to swallow capsules or a medical condition that significantly affects gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction; 11．Uncontrolled systemic infection requiring intravenous administration of drugs for parenteral anti-infective therapy.
• ．Human immunodeficiency virus (HIV) infection, or presence of serological status of active hepatitis B or C virus infection: 1）Either hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive serology can be enrolled if hepatitis B virus (HBV) DNA (\<20 IU/mL) and are willing to receive monthly HBV reactivation monitoring. 2) For patients in the presence of hepatitis C virus antibody, they could be enrolled if HCV RNA is not detected.
• ．Hypersensitivity is known to either lenalidomide or rituximab, or to chemical or biological analogues of lenalidomide and rituximab.
• ．Women during pregnancy or lactation. 15．Any life-threatening disease, medical condition, or incomplete organ system as considered by the investigator that may affect the safety of the subject or lead to the study risk.
• ．History of deep venous thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months.

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (1)

Qingdao central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

MeSH Terms

Interventions

Rituximab; zanubrutinib; Lenalidomide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: May 26, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (1)