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

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04460248
• Other study ID #: ZR2
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 22, 2020
• Est. completion date: August 2023

Study information

• Verified date: April 2022
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 2023
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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):

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• 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: 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.

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single-cell ribonucleic acid (scRNA) sequencing	scRNA sequencing in tumor tissue	From enrollment to study completion, a maximum of 3 years.
Primary	Complete response rate		At the end of Cycle 6 (each cycle is 21 days)
Secondary	2-year progression-free survival		2 years after enrollment
Secondary	2-year overall survival		2 years after enrollment
Secondary	Incidence rate of adverse events		From enrollment to study completion, a maximum of 3 years.