search
Back to results

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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zanubrutinib, Lenalidomide and Rituximab (ZR2)
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Ruijin Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zanubrutinib, Lenalidomide and Rituximab (ZR2)

Arm Description

Outcomes

Primary Outcome Measures

Complete response rate

Secondary Outcome Measures

2-year progression-free survival
2-year overall survival
Incidence rate of adverse events

Full Information

First Posted
June 25, 2020
Last Updated
April 19, 2022
Sponsor
Ruijin Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04460248
Brief Title
Zanubrutinib, Lenalidomide and Rituximab (ZR2) in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
February 16, 2022 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zanubrutinib, Lenalidomide and Rituximab (ZR2)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib, Lenalidomide and Rituximab (ZR2)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete response rate
Time Frame
At the end of Cycle 6 (each cycle is 21 days)
Secondary Outcome Measure Information:
Title
2-year progression-free survival
Time Frame
2 years after enrollment
Title
2-year overall survival
Time Frame
2 years after enrollment
Title
Incidence rate of adverse events
Time Frame
From enrollment to study completion, a maximum of 3 years.
Other Pre-specified Outcome Measures:
Title
Single-cell ribonucleic acid (scRNA) sequencing
Description
scRNA sequencing in tumor tissue
Time Frame
From enrollment to study completion, a maximum of 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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): 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
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs