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

Shanghai Jiao Tong University

Status and phase

Active, not recruiting

Phase 2

Conditions

Diffuse Large B Cell Lymphoma

Treatments

Drug: Zanubrutinib, Lenalidomide and Rituximab (ZR2)

Study type

Interventional

Funder types

Other

Identifiers

NCT04460248

ZR2

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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